SUMMARY OF CHANGES
Revision 1, Version Date: November 5, 2002
RTOG BR-0119, A Randomized Phase II Study Of A.M. And P.M. Melatonin For Brain Metastasis In RPA Class II Patients
Study Chair: Lawrence Berk, M.D., Ph.D., 740-344-3100, FAX # 740-344-5793, lbberk@radiation-oncology.com
IRB Review Requirements:
( ) Full board review required
(X) Expedited review allowed
( ) No review required
RTOG BR-0119 has been revised as follows:
Title page — Dr. Berk’s affiliation and street address were updated; Dr. Hrushesky was added as Medical Oncology study chair; Dr. Blask is now the Experimental Oncology study chair.
Schema page — was corrected to indicate that treatment must begin within 14 (versus 10) days of radiographic documentation of brain metastases, to correspond to Section 4.0; this change also was made in Sections 6.1 and 7.1.
Section 3.1.6 — The phrase, “who are of reproductive age and/or who are sexually active”, was added for clarity; this change also was made to the Eligibility list on the Schema page and to the Eligibility Checklist, page 1, question 9. Appendix IA, sample consent, was similarly clarified under risks associated with melatonin, last paragraph.
Section 10.0 — The following changes were made:
- In Section 10.1.1, the last two sentences were added for clarity.
- Section 10.2 was divided into two subsections, 10.2.1 and 10.2.2, and the sentence, “For patients who have consented to participate in the serum component of the study” was added;
- Details of specimen collection and storage were added to Section 10.2.2;
- Section 10.3 was substantially revised with details of shipment and RTOG standard Tissue Bank details added;
- Details of reimbursement were deleted from Section 10.3.1; RTOG standard reimbursement details were added as Section 10.4;
- The RTOG standard confidentiality information was added as Section 10.5, and the process involved in patients withdrawing consent was explained in Section 10.5.2.
Section 11.1 — The table heading was corrected to “Interval In Months from Start of RT” (versus “End of RT”); this change also was made in Section 11.2.1 and in Appendix IA, sample consent, under the last item in study tests and procedures, “Follow-up visits with your doctor every 4 weeks from the start of radiation therapy…”.
Appendix IA — Under “Why Is This Study Being Done”, the last paragraph concerning collection of blood for research was deleted as blood used for research is described in detail in Appendix IB; under “What Are My Rights As A Participant?”, the 2nd paragraph was updated to RTOG standard concerning monitoring of phase I/II studies; under “Signature”, the line requiring the name/signature of the person obtaining consent was added to update the consent to RTOG standard.
Appendix IB — In response to the requests of several site IRBs, this consent was revised to be protocol specific; As only blood is being collected in this study, “Tissue” was removed from the heading, and all references to and explanations about tissue collection for research were deleted from the consent form. In addition, the following changes were made:
- Under “About Using Blood For Research”, the first paragraph was revised for clarity; the second and third paragraphs were added to update the consent to RTOG standard.
- Under “Things To Think About”, paragraphs two and three were updated to RTOG standard.
- The section, “Risks”, was updated to RTOG standard.
- The “Participant statement” and “Witness statement” were added to update the consent to RTOG standard.
A revised protocol is available (no password required) on the RTOG website: http://www.rtog.org/