Radiation Therapy

Oncology Group

Welcome to the RTOG Welcome to the RTOG Research Associate Research Associate

OrientationOrientation

Tampa February 2007Tampa February 2007

Radiation Therapy

Oncology Group

PROTOCOLSPROTOCOLS

Radiation Therapy

Oncology GroupProtocol DesignProtocol Design

• Types of Studies• Protocol Format• Protocol Development and Activation• Preparation for Study Participation

Radiation Therapy

Oncology GroupTypes of StudiesTypes of Studies

• Phase I• Phase II• Phase I/II• Randomized Phase II• Phase III• Lab Correlates• Cancer Control• Randomized vs. Non• Intergroup

Radiation Therapy

Oncology GroupPhase I, II, I/IIPhase I, II, I/II

• I Determine the maximum tolerated dose. Investigational drugs .

• II Response to treatment (extent of tumor reduction).

• I/II Early and late endpoints: dose searching studies.

Radiation Therapy

Oncology GroupPhase III StudiesPhase III Studies

Randomized prospective comparisonof experimental regimens.

Larger number of participants (4000).Followed for a longer period of time.End point may be response duration

and survival.

Radiation Therapy

Oncology GroupReason for RandomizationReason for Randomization

• Patients can be assigned to 2 or more treatment regimens.

• Minimizes bias and balances stratification factors (age, weight loss, stage of current disease).

• Provides the greatest credibility.

Radiation Therapy

Oncology Group

• Laboratory correlates

• Cancer control

• Intergroup

Radiation Therapy

Oncology GroupStudy ClassificationsStudy Classifications

• Single Blind• Double Blind• Single Arm• Multiple Arm

Radiation Therapy

Oncology GroupProtocol FormatProtocol Format

Radiation Therapy

Oncology GroupSections of ProtocolSections of Protocol

• Schema• Eligibility Check• 1.0 Introduction• 2.0 Objectives• 3.0 Patient Selection

Radiation Therapy

Oncology GroupSections of ProtocolSections of Protocol

• 4.0 Pretreatment Evaluations• 5.0 Registration Procedures• 6.0 Radiation Therapy• 7.0 Drug Therapy

Radiation Therapy

Oncology GroupSections of Protocol, ContinuedSections of Protocol, Continued

• 8.0 Surgery• 9.0 Other Therapy• 10.0 Pathology/TRP Correlates• 11.0 Patient Assessments

Radiation Therapy

Oncology GroupSections of Protocol, ContinuedSections of Protocol, Continued

• 12.0 Data Collection• 13.0 Statistical Considerations• References• Sample Consent• Appendices

Radiation Therapy

Oncology Group

Protocol DevelopmentProtocol Developmentand Activationand Activation

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology Group

Comprehensive Review Comprehensive Review Mechanism & Group StrategyMechanism & Group Strategy

• Concept review and feasibility survey• Group review• Internal review• NCI review (generating a re-review by

group and study chair)• Activation• Revisions

Radiation Therapy

Oncology GroupRTOG Web SiteRTOG Web Site

•http://www.rtog.org

Radiation Therapy

Oncology GroupPreparation for Study ParticipationPreparation for Study Participation

Radiation Therapy

Oncology GroupPreparation for Case EntryPreparation for Case Entry

• Review Eligibility Requirements (sect.3.0) -complete eligibility list

-questions to RA at HQ prior to registration

• Review Required Studies & Labs--did they occur within required time frame?

• Review Feasibility for Success--should this patient be entered on study?

Radiation Therapy

Oncology GroupRegistration ProceduresRegistration Procedures

• Mandatory Web Registration – Available 24 hours a day/7 days a week

• Intergroup Registration – Fax Eligibility Checklist to 215-574-0300

• IMPORTANT REMINDERS: **Complete Eligibility Checklist**Signed and Dated Informed Consent**Patients must be registered prior to the start of any protocol treatment

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology Group

Go to RA Corner forUser Authorization Form

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology GroupConfirmation of Web RegistrationConfirmation of Web Registration

• Following a successful Web Registration you will receive: – Treatment Assignment and

Case Number– E-Mail Confirmation

• A0• Patient Calendar**Check carefully for errors

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology Group

From: CONFIRMATION [CONFIRMATION@rtog.org]To: brenda_youngSubject: ACR New Case Registration for Study No - 9998 and Case No -0034 Hello, The Confirmation of New Case Registration for the American College Of Radiology Study# 9998 Case# 0034.Please Find the attached A0 & Patient Calendar HTML File.  Thanks, ACR  Note: This information E-mail is Auto generated by the Clinical Server On Wed Jan 14 12:44:00 EST 2004 (Eastern Standard Time).Replies will not be checked on this server, so please send your Queries to HQ directly for prompt response. 

Email ConfirmationEmail Confirmation

Radiation Therapy

Oncology Group

Calendars and Data ScheduleCalendars and Data Schedule

Purpose Record / log forms Form description Changes to

calendar Calendar extension

Jan 2006

Radiation Therapy

Oncology GroupPURPOSEPURPOSE Verification of assignment & case number Institution name / number Patient identification / number Calendar base date Timetable data / form submission Access to real-time calendars for all

cases via RTOG Data Log In Center on website

Radiation Therapy

Oncology Group

Example:Hard Copy Calendar

Radiation Therapy

Oncology Group

Example: Web Calendar

Radiation Therapy

Oncology Group

RECORD / LOG FORMSRECORD / LOG FORMS

list of forms according to due date

all forms are per section 12.0 of protocol

each form requires a response

Radiation Therapy

Oncology Group

ID / Description of FormsID / Description of Forms

Form identification via two descriptors * form title * two letter ID code

Radiation Therapy

Oncology Group

Radiation Therapy

Oncology GroupPatient StatusPatient Status

Alive Dead Lost

Radiation Therapy

Oncology GroupPatient StatusPatient Status

• Alive * data submission is as per calendar

• Dead* data due prior to date of death becomes due* Z1 remains due until response is received

• Lost* Cannot obtain patient status / information for

• > 3 years* V5• Need to document all efforts

to establish patient’s status.

Radiation Therapy

Oncology Group

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