A R B E I T S G E M E I N S C H A F T D E R M A T O L O G I S C H E O N K O L O G I E · A D O

W W W . A D O - H O M E P A G E . D E

Dermatologic CooperativeOncology GroupDeCOG

2

TABLE OF CONTENTS

3 Mission statement

4 Map of Germany with top 35 DeCOG study centers

5 Executive board and presidents

7 Awards received by DeCOG members

7 Main areas of interest:• What can we offer?• Basic, translational and clinical research• Guidelines for management of skin tumors• Educational activities

10 Interdisciplinary melanoma centers and their certification

11 List of DeCOG trials

14 Registries and Networks• Merkel Cell Carcinoma Registry• Central Malignant Melanoma Registry

in Germany• Nevus Network• Central Cutaneous Lymphoma Registry

15 Committees

3

MISSION STATEMENT

COMPETENCE BUILDS CONFIDENCE!

The DeCOG (Dermatologic Cooperative OncologyGroup) is affiliated with the German Cancer Society(DKG) and the German Dermatologic Society (DDG). It was founded in 1990 to combine forces in the fightagainst skin cancer.

The DeCOG is an independent non-profit organizationdedicated to an interdisciplinary and professional ex-change of scientific information and the organization ofprojects in the field of skin cancer.

The DeCOG promotes dermato-oncology to increasethe quality of care for skin cancer patients and to estab-lish standards for skin cancer detection and treatment.

The DeCOG carries out and collaborates in high quali-ty clinical trials and scientific projects in skin cancer in-cluding early detection, clinical diagnosis, and therapy,as well as experimental research.

The DeCOG organizes educational events, providesmaterials and promotes the scientific exchange aboutskin cancer topics.

The DeCOG promotes collaboration and exchange ofinformation with other medical disciplines and cancersocieties.

These goals are supported by several committees ofthe DeCOG: The committee of clinical trials, education,translational research, clinical guidelines in dermato-oncology, quality assurance, outpatient dermato-onco-logy, skin cancer registries, health services research,committee transplantation in the dermato-oncology,committee supportive care and the committee of pu-blic relations.

4

THE 35 LEADING MELANOMA STUDY CENTERSWITHIN THE DECOG

• Kiel• Tübingen• Homburg/Saar• Mannheim• Erfurt• Berlin Charité• Regensburg• (Zürich)• Frankfurt/M.• Hannover• Heidelberg• Minden• Magdeburg• Hamburg UKE• Dresden Uniklinik• Würzburg• Buxtehude• Jena• München LMU• Münster• Erlangen• Lübeck• Wuppertal • Hildesheim• Bochum• Köln• Berlin Neukölln• Freiburg• Essen• Oldenburg• München TU• Mainz• Berlin Prenzlauer Berg• Dresden Friedrichstadt• Augsburg

5

EXECUTIVE COMMITTEE AND PRESIDENTS

The present executive committee of DeCOG waselected on 29th September 2006, by the general assembly at the 2006 Annual Meeting in Bochum,Germany.The executive committee is elected for 2 years.The next election will be at the DeCOG Annual Conference in September 2008.

President: Axel Hauschild, MDVice President: Dirk Schadendorf, MDGeneral Secretary: Matthias Volkenandt, MDTreasurer: Peter Mohr, MDBoard of Directors: Jürgen Becker, MD PhD

Cornelia Mauch, MD PhDUwe Reinhold, MDJens Ulrich, MD

Axel Hauschild, MDProfessor of DermatologyClinic for Dermatology, Venerolo-gy and Allergology University Clinics Campus KielSchittenhelmstraße 724105 Kiel · GermanyPhone: +49 (0)431 / 597-1613Fax: +49 (0)431 / 597-1853ahauschild@dermatology.uni-kiel.dewww.dermatology.uni-kiel.de

Dirk Schadendorf, MDProfessor of DermatologyUniversity Clinic EssenClinic of Dermatology and VenerologyHufelandstraße 5545147 Essen · GermanyPhone: +49 (0)201 / 723 - 2431Fax: +49 (0)201 / 723 - 244Dirk.Schadendorf@uk-essen.de www.uniklinikum-essen.de

Matthias Volkenandt, MDProfessor, Clinic and Policlinic for DermatologyLudwig-Maximilians-UniversityFrauenlobstraße 9-1180337 Munich · GermanyPhone: +49 (0)89 / 5160-6225Fax: +49 (0)89 / 5160-6226Matthias.Volkenandt@med.uni-muenchen.de derma.klinikum.uni-muenchen.de

Peter Mohr, MDElbe Clinics – DermatologicalCenter BuxtehudeAm Krankenhaus 121614 Buxtehude · GermanyPhone: +49 (0)4161 / 703-0Fax: +49 (0)4161 / 703-6445Peter.Mohr@elbekliniken.dewww.elbekliniken.de

Jürgen C. Becker, MD PhDProfessor, Clinic and Policlinic for Dermatology, Venerology and AllergologyUniversity Clinics WürzburgJosef-Schneider-Straße 297080 Würzburg · GermanyPhone: +49 (0)931 / 201-26396Fax: +49 (0)931 / 201-26462becker-jc.derma@mail.uni-wuerzburg.de www.klinik.uni-wuerzburg.de/hautklinik

Cornelia Mauch, MD PhDClinic and Policlinic for Dermatology and VenerologyCologne University Kerpener Straße 62 50937 Cologne · GermanyPhone: +49 (0)221 / 478-86194 Fax.: +49 (0)221 / 478-87060 cornelia.mauch@uk-koeln.dewww.medizin.uni-koeln.de/kliniken/dermatologie/klinik/klinik.html

6

Uwe Reinhold, MDMedical Center BonnFriedensplatzDepartment of Dermatology, Allergology, Dermato-OncologyFriedensplatz 1653111 Bonn · Germany

Phone: +49 (0)228 / 22720-0Fax: +49 (0)228 / 22720-100u.reinhold@medizinisches-zentrum-bonn.dewww.medizinisches-zentrum-bonn.de

Jens Ulrich, MDClinic for Dermatology and Allergology, Clinical CenterQuedlinburg Academic TeachingHospital of the Otto-von-Gueri-cke-University Magdeburg

Ditfurter Weg 24, 06484 Quedlinburg · GermanyPhone: +49 (0)3946 / 909-1580Fax: +49 (0)3946 / 909-1585j.ulrich@klinikum-quedlinburg.dewww.klinikum-quedlinburg.de

1994-2002Claus Garbe, MDProfessor and Head, Division ofDermato-oncology, Departmentof Dermatology, University Medical Center Tübingen

Liebermeierstraße 25, 72076 Tübingen · GermanyPhone: +49 (0)7071 / 29-87110Fax: +49 (0)7071 / 29-5187claus.garbe@med.uni-tuebingen.dewww.dermonko.de, www.hautkrebs.de

1992-94 Günter Burg, MDProfessor and former Chairman,Department of Dermatology,University of ZürichCurrent address: Haldenstr. 14 ,8124 Maur / Switzerland

Phone/Fax +41 44 9802568 Natel/Handy +41 79 7685648 Email: burg@derm.uzh.ch

1990-92Johannes Petres, MDFormer Chairman, Departmentof DermatologyKassel City ClinicsDeceased in 2008

PAST PRESIDENTS

Awards Received by DeCOG MembersThe DeCOG members are active in clinicaland scientific fields. Members of the DeCOGregularly receive renowned prizes andawards. We would like to mention only a few:

German Cancer Awardwww.krebsgesellschaft.de/wub_krebspreis,936.html

1995: Claus Garbe, Tübingen2003: Reinhard Dummer, Zürich2004: Jürgen Becker, Würzburg2006: Gerold Schuler, Erlangen2008: Peter Friedl, Würzburg

German Skin Cancer Award of the German Skin CancerFoundationwww.hautkrebsstiftung.de/start.html

2001: Uwe Reinhold, Homburg; Jürgen Becker, Würzburg

2002: Hans Starz, Augsburg2003: Beatrice Schuler-Thurner,

Erlangen; Axel Hauschild, Kiel

2004: Peter Friedl, Würzburg2006: Mirjana Urosevic, Zürich;

Margarete und Michael Schön, Würzburg

2007: Anja Bossenhoff, Regensburg

7

MAIN AREAS OF INTEREST

The Dermatologic Cooperative Oncology Group (De-COG) initiated a huge clinical trial program for melano-ma, cutaneous lymphomas, epithelial skin cancer anddermatofibrosarcoma protuberans almost 14 yearsago. The network of the society allows us to recruit suf-ficient numbers of patients for all skin cancers. Forexample, we are currently enrolling 25 patients permonths into adjuvant melanoma and 20 patients permonths into stage IV melanoma trials. Typically, De-COG trials are investigator-initiated trials (IITs) in closecollaboration with pharmaceutical companies. Colla-boration with other cooperative groups for skin canceris frequent and always an advantage from our per-spective. Apart from clinical trial endpoints, we are in-terested in translational research projects, typically at-tached to clinical trials. We have a broad platform ofDeCOG centers with an expertise in basic and transla-tional research. Correlating biomarker studies and mo-nitoring evaluation during clinical trials using a hugevariety of different research techniques are available.We strongly believe that clinical trials should includetranslational studies to increase the likelihood of suc-cess in the future! A Germany-wide DeCOG biobanking

initiative for melanoma is approaching rapidly. TheGerman Melanoma Registry for epidemiological andclinical observation is internationally well known.Along with our research activities, we have developedevidence-based guidelines for the care of patients witha variety of skin tumors. The DeCOG represents theGerman Cancer Society as well as the German Derma-tologic Society in a multidisciplinary setting. S2 guide-lines have been published and there is a grant applica-tion for S3 guidelines for melanoma and epithelial skincancer. Furthermore, the DeCOG is the leading society for edu-cation in the dermato-oncology area in Germany. Wecollaborate with sister societies and colleagues in Austria and Switzerland and furthermore with the European Association of Dermato-Oncology (EADO).Our educational campaigns have led to a large numberof educational sessions including teaching sessions onhow to perform clinical trials that conform to Good Clinical Practice (GCP). We are represented at almostall interdisciplinary oncology meetings in Germany andinternationally in educational programs by our opinionleaders.

8

DeCOG: WHAT CAN WE OFFER?

• an active and relatively young dynamic society forcollaboration

• an excellent infrastructure of skin cancer centerswith high expertise (an initiative for “CertifiedInterdisciplinary Skin Cancer Centers”)

• global contacts with almost all collaborative groupsand major skin cancer / melanoma centers

• planning and implementation of phase I-IV trialsfor all types of skin tumors (melanoma, cutaneous lymphoma, epithelial skin cancer, rare neoplasias)

• development of investigator-initiated trials inclu-ding statistics, biometry and CRF developmentwhich conform to GCP

• rapid enrollment of skin cancer patients into clinical trials

• advice in the product development and discussionwith regulatory agencies in Germany and Europe

• development of evidence-based guidelines for skinmalignancies

• broad basic and translational research expertise inmajor DeCOG centers (including initiatives for acentralized biobanking systems)

• broad experience in publishing basic, translationaland clinical research

Ask us about our expertise in other areas!

BASIC, TRANSLATIONAL AND CLINICAL RESEARCH

The prerequisite for any rational, evidence-based undultimately successful therapy is an understanding forthe underlying disease. The DeCOG has created a net-work which brought together basic, translational andclinical research groups now tackling carcinogenesisand particularly melanomagenesis.Early stages of melanoma are successfully treated withsurgery in the majority of cases, but advanced diseaseis generally refractory to conventional chemotherapy.There is therefore much interest in the field in novel therapeutics, specifically immunotherapy andtargeted therapies. Our understanding of this complexand often unpredictable disease is expanding basedon new developments in immunology and tumor gene-tics.While basic knowledge may be generated by useof in vitro and preclinical in vivo systems, such resultsneed to be validated in human disease. To ensure this

translational research, the DeCOG established an internet-based databank together with a linked decen-tralized biobank including tumor tissue, tumor and somatic DNA, serum, and peripheral blood. Most notably, this biobank was largely derived from patientstreated within clinical trials making it possible to estab-lish the predictive value of biomarkers for treatmentoutcome. New therapeutic approaches, besides mo-noclonal antibodies and vaccination, include an increasing number of small molecules that have beenshown to interfere restrictively with intracellular signa-ling pathways in melanoma and decrease proliferation,survival, migration or invasion. Other agents can inter-fere with stromal components of melanoma, such asangiogenesis and components of the immune system.This large variety of possible treatment options calls onone hand for controlled clinical trials combined withbasic and translational research to establish new instruments and algorithms’ for a stratified or even individualized medicine.

Fig. 1: Visualization of actin fibers in tumor cells before andupon hyper-activation of the MAPK pathway (from Houbenet al. J. Invest. Dermat. 2007)

Fig. 2: Overall survival of patients receiving immune modula-tors according the genotype of the immune response geneCCR5 (from Ugurel et al.Cancer Immunol Immunother.2008)

CCR5 wt/wt

% s

urvi

val

CCR5 Δ32/Δ32; CCR5 wt/Δ32

0 10 20 30 40 50 60

100

75

50

25

0

months

9

GUIDELINES FOR MANAGEMENT OF SKIN TUMORS

Guidelines have been developed in an interdiscipli-nary fashion under the auspices of the GermanCancer Society and the DeCOG since 1996. Theseguidelines have been written in order to help clinici-ans diagnose, treat, and follow skin cancer patients.They help caregivers improve the management ofskin cancer patients. The guidelines are also inten-ded to promote the integration of care betweenmedical and paramedical specialties for the benefitof the patient.These guidelines have been established by interdis-ciplinary expert groups which analyze all relevantinternational literature; they are then approved by

the relevant medical professional asso-ciations. They take into considerationthe present standard of knowledge anddescribe “state of the art” diagnosticand therapeutic approaches. Approvalhas been obtained from the differentscientific specialty groups, coordinatedby the Information Center for Standardsin Oncology (ISTO, German CancerSociety). Eight different working partiesof the German Cancer Society took part

in this process. The Association of the ScientificMedical Societies in Germany organized the processof approval with 11 different scientific medical socie-ties. Claus Garbe, MD, Tübingen, coordinated theactivities of the various groups, the selected experts,and the final authors. Guidelines were establishedfor the following tumors and have been published ina long version and as brief guidelines:

• Malignant melanoma of the skin • Basal cell carcinoma • Squamous cell carcinoma • Merkel cell carcinoma • Dermatofibrosarcoma protuberans • Kaposi sarcoma• Cutaneous lymphomas • Melanocytic nevi• Actinic keratosisThe current Germany melanoma guidelines arepublished in Melanoma Research:

Garbe C, Hauschild A, Volkenandt M et al.: Evidence-based and interdisciplinary consensus-ba-sed German guidelines: systemic medical treatment

of melanoma in the adjuvant and palliative setting,Melanoma Res. 2008 Apr;18(2):152-160Garbe C, Hauschild A, Volkenandt M et al: Evidence and interdisciplinary consensus-based Germany guidelines: surgical treatment and radiotherapy of melanoma. Melanoma Res. 2008 Feb;18(1):61-7Garbe C, Hauschild A, Volkenandt M et al.:Evidence and interdisciplinary consensus-based Germany guidelines: diagnosis and surveillance ofmelanoma. Melanoma Res. 2007 Dec;17(6):393-9

EDUCATIONAL ACTIVITIES

In order to improve the quality of care of patients withskin cancer the Dermatologic Cooperative OncologyGroup (DeCOG) has initiated a broad educationalprogram, which is offered to dermato-oncologistsaround the country. Various programs covering the standard as well as experimental treatment of malignant melanoma, epithelial skin tumors, cutaneous lymphomas andMerkel cell carcinoma have been developed and areregularly offered:• A half-day educational symposium of practical

dermato-oncology is provided quarterly in variouscities of Germany for all dermato-oncologists of theregion.

• As part of the annual meeting of the GermanCancer Society (Deutsche Krebsgesellschaft), ahalf-day interdisciplinary educational symposium isoffered. A similar symposium is offered as part ofthe biannual meeting of the German Dermatologi-cal Society (“Deutsche Dermatologische Gesell-schaft”).

• Several courses teaching how to perform clinicalstudies conforming to GCP-standards have beenoffered.

• Annually since 2006, a 40-hour course systemati-cally covering all aspects of medical therapy ofmalignant skin tumors is offered. Approximately 80 – 100 dermato-oncologists attend. Those whopass the written exam achieve a certificate validfor 5 years.

• Members of the board of the DeCOG are frequentspeakers at educational activities initiated by othercancer societies.

Interdisciplinary Guidelines for the diagnostic and treat-ment of skin tumors

10

INTERDISCIPLINARY MELANOMA CENTERSAND THEIR CERTIFICATION

Skin Cancer Center(SCC)

Steps to the Certified Skin Cancer Center

OnkoZertCertification Institute of the

German Cancer Society (GCS)

CertificationCommission

GCS approved experts

Board of Certification

GCS approved experts

KTQ/ISO 9001Certifying Institutes

Requirements of SCC

- Elaboration of SC questionnaire

- Identification of deficits compared to requirements for SCC

Introduction QA-System

- Selection of QA-Model (ISO 9001 or KTQ)

- Establishment of QA system- Selection of QA certifying institute

Start of SCC Certification

- Application for SCC Certification

- Selection of experts

- Planning of certification audit

- Check of questionnaire

- Approval for cerification process

Certification audit Certification QA system

Introduction of changes according to requirem Review by Board of Certification

Certification by GCS

Certification of Skin Tumor Centers

Development of interdisciplinary guidelines

Dermato- Surgery

• tumor excisions

• micrographic surgery

• plastic &reconstructive surgery

• SLNB

Medical Therapy

• chemotherapy

• immune therapy

• targeted therapy

• vaccination

ExperimentalResearch

• molecular biology

• cell culture

• animal testing

• immunology

Clinical Research

• clinical studies

• epidemiology

• blood and tissue bank

Patient Follow up

• structured examination

• radiologicalexaminations

• tumormarker

• documentation

11

LIST OF CLINICAL TRIALS

1. TRIALS CLOSED FOR RECRUITMENT:

1.1 ADJUVANT TRIALS in MELANOMA STAGEII/III

Short title: DeCOG-MM-ADJ-0 (PI: G. Burg, MD andR. Dummer, MD)Title: Prospective randomized trial of interferon alpha-2b and interleukin-2 as adjuvant treatment forresected intermediate- and high-risk primary melanoma without clinically detectable node metastasisEnd of recruiting: 1995No of patients: 225Publications: A Hauschild, M Weichenthal, BR Bal-da, JC Becker, HH Wolff, W Tilgen, KW Schulte, J Ring, D Schadendorf, S Lischner, G Burg, R Dum-mer, 2003, J Clin Oncol, 21(15): 2883-2888R Dummer, A Hauschild, T Henseler, G Burg. 1998,THE LANCET, 352: 908-909

Short title: DeCOG-MM-ADJ-1 (PI: C. Garbe, MD)Title: Randomized multicenter study protocol on theefficacy of an adjuvant treatment with INF-2-alpha(Roferon-A) or a combination of IFN-2-alpha andDTIC versus studying melanoma patients with lymphnode metastases (stage IIIB) End of recruiting: 2001No of patients: 444 Publication: C. Garbe, P. Radny, R. Linse, R. Dummer, R. Gutzmer, J. Ulrich, R. Stadler, M. Weichenthal, T. K. Eigentler, U. Ellwanger, andA. Hauschild, *(2007) Ann Oncol

Short title: DeCOG-MM-ADJ-2 (PI: A. Hauschild, MD)Title: Randomized multicenter study on the efficacyof different interferon-a-2b doses (Intron-A) in the adjuvant therapy of melanoma patients with high-riskprimary tumors (tumor thickness > 1.5 mm; DDG-stage IIA+B)End of recruiting: 2001No of patients: 674 Publication: (manuscript in preparation).

Short title: DeCOG-MM-ADJ-3 (PI: C. Garbe, MD)Title: Prospective-randomized study on the efficacyof an adjuvant therapy of the metastatic melanomawith vindesin versus studying patients after an operativeresection of metastases (stage IIIA, IIIB-relapse, IV) End of recruiting: 2001No of patients: 142 Publication: (manuscript in preparation)

Short title: DeCOG-MM-ADJ-4 (PI: A. Hauschild, MD)Title: Randomized multicenter study on the efficacyof interferon-alpha-2a doses (Roferon-A) in the adjuvant therapy of melanoma patients with high-riskprimary tumors (tumor thickness > 1.5 mm; DDG-stage IIA+B) for a period of 18 vs. 60 months End of recruiting: 2004No of patients: 880Side study QoL : Title: Neurotoxicity adverse eventsPublication: (manuscript to be prepared in 2008)

Short title: DeCOG-MM-ADJ-6 (PI: C. Garbe, MD) inco-operation with EADOTitle: Randomized, multicenter phase III trial compa-ring adjuvant treatment with PegIntron over 36months versus reference treatment with IntronA over 18 months in cutaneous melanoma patientsAJCC Stage II (>1.5 mm, clinically node negative)End of recruiting: 2005No of patients: 890

Short title: DeCOG-MM-ADJ.-9 (PI: C. Garbe, MD)Title: Randomized, multicenter, open label study tocompare the efficacy and tolerability of pegylated interferon-alpha-2a (PEG-IFN) to “low dose” interferon-alpha-2a in patients with malignant melanoma in stages IIA (T3a) – IIIB (AJCC-2002)End of recruiting: 2007No of patients: 880

12

1.2 TRIALS in MELANOMA STAGE IV (closed & published)

Short title: DeCOG-MM-PAL-1 (PI: W. Tilgen, MD)Title: Randomized, multicenter study on the efficacyof a combined treatment with DTIC and IFN-a versusa combination of DTIC, IFN-a and IL-2 on malignantmelanoma patients in the stage of distant metastasis(stage IV) End of recruiting: 1998No of patients: 290 Publication: A Hauschild, C Garbe, W Stolz, U Ell-wanger, S Seiter, R Dummer, S Ugurel, G Sebastian,D Nashan, R Linse, W Achtelik, P Mohr, R Kaufmann,M Fey, J Ulrich & W Tilgen (2001) Br J Cancer. 84(8):1036-42.

Short title: DeCOG-MM-PAL-2 (PI: R. Kaufmann, MD)Title: Randomized, multicenter study on the efficacyof a combined treatment with temozolomide and interferon alpha versus temozolomide alone on malignant melanoma patients in the stage of distantmetastasation (stage IV) End of recruiting: 2001No of patients: 294 Publication: R Kaufmann, K Spieth, U Leiter, CMauch, P von den Driesch, T Vogt, R Linse, W Tilgen,D Schadendorf, JC Becker, G Sebastian, S Krengel, L Kretschmer, C Garbe, R Dummer (2005). J Clin Oncol 23 (35): 9001-7

Short title: DeCOG-MM-PAL-2A (PI:. R. Kaufmann, MD)Title: Randomized, multicenter study on the efficacyof a first-line treatment of the combined treatmentwith temozolomide and pegylated interferon alphaversus temozolomide alone on stage IV melanomapatients End of recruiting: 2004No of patients: 125 Publication: K Spieth, R Dummer, U Leiter, C Garbe,J Gille, JC Becker, A Hauschild, W Tilgen, R Kaufmann, D Schadendorf , (2003) Ann Oncol19(4):801-6

Short title: DeCOG-MM-PAL-3 (PI: D. Schadendorf, MD)

Title: Second-line therapy with weekly paclitaxel andcarboplatin versus paclitaxel alone in melanoma pa-tients with distant metastases (stage IV) End of recruitment: 3/2000No of patients: 40 Publication: C Zimpfer-Rechner, U Hofmann, R Figl,J C Becker, U Trefzer, I Keller, A Hauschild, D Schadendorf (2003) - Melanoma Res 13: 531-536.

Short title: DeCOG-MM-PAL-4 (PI: D. Schadendorf, MD)Title: Randomized, multicenter study on the efficacyof dacarbazine (DTIC) versus vaccination with autolo-gous peptide-pulsed dendritic cells (DC) in first-linetreatment of patients with metastatic melanoma: arandomized phase III trial (stage IV) End of recruiting: 3/2003No of patients: 108 Publication: D Schadendorf, S Ugurel, B Schuler-Thurner, FO Nestle, A Enk, EB Bröcker, S Grabbe, W Rittgen, L Edler, A Sucker, C Zimpfer-Rechner, T Berger, J Kamarashev, G Burg, H Jonuleit, A Tüttenberg, JC Becker, P Keikavoussi, E Kämpgen,G Schuler (2006). Ann Oncol. 17(4): 563-70

Short Title: DeCOG-MM-PAL-5 (PI: D. Schadendorf, MD)Title: Clinical phase II study on the efficacy of a treat-ment with temozolomide with different doses in pa-tients with asymptomatic brain metastases from mali-gnant melanoma in the stage of distant metastases(stage IV)End of recruiting: 4/2004No of patients: 45 Publication: D Schadendorf, A Hauschild, S Ugurel,A Thoelke, F Egberts, M Kreissig, R Linse, U Trefzer,T Vogt, W Tilgen, P Mohr, C Garbe (2006) Ann Oncol, 17(10): 1592-7.

Short title: DeCOG-MM-PAL-6 (PI: U. Reinhold, MD)Title: Multi-center phase-II study for a first-line selective chemotherapy after pre-therapeutic sensiti-vity-directed chemotherapy in metastatic melanomapatients End of recruiting: 04/2004No of patientsl: 82 Publication: S Ugurel, D Schadendorf, C Pföhler,

13

K Neuber, A Thoelke, J Ulrich, A Hauschild, K Spieth,M Kaatz, W Rittgen, D Delorme, W Tilgen, U Reinhold(2006) - Clin Cancer Res 12(18): 5454-63.

Short title: Protocol DeCOG MM-PAL-8 (PI: Jens Ulrich, MD)Title: Standard palliative care versus standard palliati-ve care plus polychemotherapy in metastasized mali-gnant melanomaEnd of the recruitment: 09/2006No. of patients: 120Publication: in preparation

1.3 Dermatofibrosarcoma protuberans (closed)

Short title: DeCOG-DFSAP-1 (PI: D Schadendorf, MD)Title: Open-label Trial of Glivec® (imatinib mesylate)in patients with dermatofibrosarcoma protuberans End of recruiting: 5/2006No of patients : 17Publication: S Ugurel, J Utikal, P Mohr, P Helmbold,C Pfoehler, M Schiller, I Kellner, D Schadendorf. J Clin Oncol 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 9561

1.4 Actinic Keratoses (closed)

Short title: DeCOG-AK-1 (PI: C. Garbe, MD)Title: Randomized, multicentre, open label study tocompare the efficacy and tolerability of Solaraze® for3 months versus 6 months in patients with mild to mo-derate actinic keratoses located at the face and headNo of patients: 418Expected study end: 11/2007

1.5 Cutaneous Lymphoma (closed)

Title: A randomized, open label phase III trial to eva-luate the safety and efficacy of interferon alfa 2a main-tenance therapy compared to observation without the-rapy in patiens with a complete remission after combi-nation therapy with interferon alfa 2a plus PUVA withcutaneous T-cell lymphoma (T1-2, N0-1, M0)End of recruitment: 2006No. of patients: 138Publication: (in preparation)

2. STUDIES WITH ONGOING RECRUITMENT (MAY 2008)

2.1 Adjuvant Melanoma Trials

Short Title: DeCOG-MM-ADJ-5 (PI: P. Mohr, MD)Title: Randomized multicentre study for adjuvanttreatment of stage III (AJCC 2002) malignant melano-ma: intermittent high-dose i.v. interferon alpha-2bversus standard high-dose interferon alpha-2b thera-py

Site study: Quality of life depression and fatigue ofpatients treated with high-dose interferon alpha-2bwithin the DeCOG study (DeCOG MM-ADJ-06) (P.Mohr, MD, M. Weichenthal, MD)No of patients: 550/600 patients in 04/2008Expected study end: Q IV/2008

Short title: DeCOG-MM-ADJ-7 (PI: R. Stadler, MD)Title: Controlled and prospectively randomized trial tocompare an elective radical lymphadenectomy versus observation in patients with malignant melano-ma with tumor thickness 1.0 mm and positive senti-nel lymph node biopsy.No of patients: 2400/5000Expected study end: 2010

2.2 Melanoma Stage IV

Short title: DeCOG-MM-PAL-9 (PI: A. Hauschild. MD)Title: Combined treatment of sorafenib and pegylatedinterferon 2b in stage IV metastatic melanoma: a pro-spective non-randomized, multicenter Phase II StudyNo of patients: 9/55 in 04/2008Start of study: March/2008

2.3 Cutaneous Lymphoma

Short title: ADO-CTCL-3 (TARADO) (PI: R. Dummer, MD)Title: Multicenter therapy protocol for bexarotene(Targetin®) monotherapy for previously treated CTCLstage >Ib with unequivocal EORTC diagnosisNo. of patients: 95/200End of recruitment: 2010

14

MERKEL CELL CARCINOMA REGISTRYPurpose of Registry

This is a centralized German registry for Merkel cellcarcinoma. It is patterned after the successful centralmelanoma registry. Data of the affected patients aswell as tumor data are collected. Registration is donevoluntarily after obtained informed consent. A scientificanalysis of the data will be done at regular intervals. OrganizationProject leader: Jürgen C. Becker, MD PhDOffice: Brigitte BauerAddress:Klinik und Poliklinik für Dermatologie, Venerologie und AllergologieUniversitätsklinikum WürzburgJosef-Schneider-Straße 2, 97080 WürzburgWebside: www.ado-homepage.deEmail: merkel@ado-homepage.de

CENTRAL MALIGNANT MELANOMAREGISTRY IN GERMANY

The Central Malignant Melanoma Registry (CMMR) ofthe German Dermatologic Society was established in1983. The CMMR is a clinic-based cancer registrywhich documents patients’ data, primary tumor dataand follow-up data. More than 60 dermatologic cen-ters contribute to this data base and about 80,000cases have been registered. The data base reachesback until 1976.Epidemiologic characteristics of cu-taneous melanoma and their development over timein Germany have been evaluated based on this dataset. Case-control studies have been conducted in or-der to elucidate risk factors for melanoma develop-ment. Prognostic factors have been examined in lar-ge cohorts of melanoma patients. The TNM classifi-cation of melanoma has been influenced by scientificstudies of the CMMR. In the future, molecular epide-miologic studies will supplement the previous scienti-fic work.OrganizationProject leader: Claus Garbe MDOffice: Ulrike Leiter MD

Address:Universiäts-HautklinikLiebermeisterstr. 25, 72076 Tübingen Webside: www.uni-tuebingen.deE-mail: claus.garbe@med.uni-tuebingen.de

NEVUS NETWORK INCLUDING REGISTRY

The DeCOG supports the efforts of the Nevus-Network, a non-profit organization founded by Ger-man dermatologists offering a patient oriented webservice and registry for patients with large congenitalnevi and neurocutaneous melanocytosis.OrganizationProject leaders: Sven Krengel, MD Address:Nävus-Netzwerk S. Krengel MDMoislinger Allee 95, 23558 LübeckTel.: +49 (0) 0451/81551www.naevus-netzwerk.deRegistration Form:The registration form can be downloaded from thehomepage of the network.

CENTRAL CUTANEOUS LYMPHOMA REGISTRY

The Central Cutaneous Lymphoma Registry of theGerman Dermatologic Society was established in1998 as a clinic-based cancer registry. To date, 26clinics from all German states, have participated. After obtaining informed consent, patients completeclinical information, including TNM stage, histologyand molecular biological data as well treatment mo-dalities are documented. Recently the first evaluationof the German Central Registry for Cutaneous Lymphomas of the German Society of Dermatologywas published.OrganizationProject leader: Chalid Assaf, MDAddress:Cutaneous Lymphoma CenterSkin Cancer Center Charité Charitéplatz 1, 10117 BerlinTel.: +49 (0) 030-450518213Tel.: +49 (0) 030-84456910Website: www.charite.de/ch/dermE-mail: chalid.assaf@charite.de

REGISTRIES ANDNETWORKS

15

Committee Clinical StudiesThis group coordinates the clinical studies of DeCOGdealing with the many different types of skin cancers. • Uwe Trefzer, MD (chair)

E-mail: uwe.trefzer@charite.de

Committee on Advanced trainingThis committee coordinates advanced training courses in dermato-oncology for DeCOG members.• Matthias Volkenandt, MD (chair)

E-mail: matthias.volkenandt@med.uni-muenchen.de

Committee on Public Relations This committee is charged with presenting the interests of DeCOG to the publics. Methods include:1. Homepage: www.ADO-Homepage.de2. News letters for members3. Training sessions for public relations activities • Peter Mohr, MD (chair)

E-mail: peter.mohr@elbekliniken.de• Thomas Eigentler, MD (web site master)

E-mail: thomas.eigentler@uni-tuebingen.de

Committee on Guideline-DevelopmentThis group regularly revises the DeCOG guidelines ondiagnosis, therapy and follow-up for all the major ty-pes of skin cancer.• Claus Garbe, MD (chair)

E-mail: claus.garbe@med.uni-tuebingen.de

Committee on Translational Research/BiobankThis committee is charged with facilitating the implementation of advances in the understanding ofskin cancer into the clinical situation; thereby improving the clinical care of the patient.• Schadendorf, MD(chair)

E-mail: d.schadendorf@dkfz.de

Committee of Quality AssuranceThis committee directs the implementation of qualitystandards in all areas relevant for skin cancer patientcare in order to allow access to up-to-date diagnosticsand treatment regimens for our patients and to allowdetailed analysis of clinical practice in our centers.• Schadendorf, MD(chair)

E-mail: d.schadendorf@dkfz.de

Committee on Outpatient Dermato-OncologyThis committee attempts to optimize the interactionbetween hospital-based and outpatient, primarily private practice dermato-oncology units. Activities include 1. Surveys to investigate the current health care provision for skin cancer patients2. Development of clinical pathways that more efficiently link treatment and aftercare between inpatient and outpatient settings3. Implementing comprehensive quality managementmeasures to increase adherence to dermato-oncologicguidelines• Uwe Reinhold, MD (chair)

eMail: u.reinhold@medizinisches-zentrum-bonn.de

Committee on Skin Tumors in Organ transplantated patientsAbout 4000 organ transplantations are performed an-nually in GERMANY: The patients are then treated forthe rest of their life with immunosuppressive re-gimens which facilitate the development of epithelialskin tumors. On average the first tumors appear 3-5years after transplantation and are one of the majorcauses of mortality after transplantation. This com-mittee is charged with exploring the causes, preventi-on and care of these secondary epithelial tumors. It ispart if the European network SCOPE.• Eggert Stockfleth, MD (chair)

eMail: eggert.stockfleth@charite.de

Committee on Health Services ResearchThis committee concerns itself through a variety ofprojects with the availability of comprehensive carefor dermato-oncology patients, monitors confirmationwith guidelines and screening recommendations andserves as an important link between hospital-basedand outpatient community-based care of skin can-cers. • Matthias Augustin, MD (chair)

eMail: m.augustin@uke.uni-hamburg.de

Committee on Supportive CareThis committee is concerned with questions and re-search about palliative care in dermato-oncology, andsupports with projects and educational efforts optimalsupportive care for dermato-oncology patients.• Carmen Loquai, MD (chair)

eMail: carmen.loquai@ukmainz.de

COMMITTEES

Contact address:

Axel Hauschild, MDProfessor of DermatologyClinic for Dermatology, Venerology and Allergology University Clinics Campus KielSchittenhelmstraße 724105 Kiel · GermanyPhone: +49 (0)431 / 597-1613Fax: +49 (0)431 / 597-1853ahauschild@dermatology.uni-kiel.dewww.dermatology.uni-kiel.de

Dermatologic CooperativeOncology GroupDeCOG

Peter Mohr, MDElbe Clinics – Dermatological Center BuxtehudeAm Krankenhaus 121614 Buxtehude · GermanyPhone: +49 (0)4161 / 703-0Fax: +49 (0)4161 / 703-6445Peter.Mohr@elbekliniken.dewww.elbekliniken.de

Photograph: Gerhard Krämer, WürzburgCopyright: Dermatologic Cooperative Oncology Group (DeCOG) / Germany Cancer Society (DKG)