SUMMARY OF CHANGES
Update Date: April 28, 2004
RTOG P-0011, “PHASE III RANDOMIZED STUDY OF ADJUVANT THERAPY FOR HIGH RISK pT2-3N0 PROSTATE CANCER”
Study Chair: Richard K. Valicenti, M.D., (215) 955-5936; FAX # (215) 955-0412; richard.valicenti@mail.tju.edu
RTOG P-0011 has been updated as follows:
Eligibility Checklist — Corrected typo on the second page of the Eligibility Check. The corrected page number on page two is “page 2 of 2”.
NOTE: This is an editorial/administrative change to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as “Update Date”.
An updated protocol is available (no password required) on the RTOG website: http://www.rtog.org/
SUMMARY OF CHANGES
Amendment #3, Version Date: March 18, 2004
RTOG 0011, “PHASE III RANDOMIZED STUDY OF ADJUVANT THERAPY FOR HIGH RISK pT2-3N0 PROSTATE CANCER
Study Chair: Richard Valicenti, MD
In order to meet the needs and standards of prescribing long-term hormone therapy the following revisions were made to this protocol.
RTOG 0011 has been revised as follows:
SCHEMA b: The words “Lupron or Zoladex“ were replaced with “LHRH agonist.”
ELIGIBILITY CHECKLIST pg. 2 of 2: Question 20 was deleted. “Is the patient going to receive IMRT?”
Page 6, Section 6: The following statement was added to comply with NCI guidelines: “NOTE: INTENSITY MODULATED RT (IMRT) IS NOT ALLOWED.”
Pages 8-10, Section 7: References to Zoladex and Lupron were removed and a new “Section 7.2 LHRH agonists (such as leuprolide, goserelin, buserelin, triptorelin)” was added.
Page 15, Section 12: Office suite number added. Fax number removed as forms should be mailed and not faxed.
Page 2, Consent: References to Zoladex and Lupron were removed and the following statement was added: “For Group 1 Your doctor will prescribe a standard hormonal drug regimen for you and administer the drug per the package instructions.”
Page 5, Consent: “Risks Associated with Hormone Therapy” replaced “Risks associated with Lupron and Zoladex.””
Page 5 & 6, Consent: The statement, “In animal studies, there is an increased incidence of non-cancerous tumors of the pituitary gland, pancreas, ovary and adrenal gland with large doses of Zoladex. However, there is no evidence to date that this has been associated with cancerous or non-cancerous tumors in humans.” as removed as Zoladex is no longer necessarily prescribed.
Page 6, Consent: The following statement was removed, “The side effects described above are risks associated with a combination of the two drugs” as it no longer applies. The next sentence had the word “choose” replaced with “receive.”
SUMMARY OF CHANGES
Update Date: December 16, 2003
RTOG P-0011, “PHASE III RANDOMIZED STUDY OF ADJUVANT THERAPY FOR HIGH RISK pT2-3N0 PROSTATE CANCER”
Study Chair: Richard K. Valicenti, M.D., (215) 955-5936; FAX # (215) 955-0412; richard.valicenti@mail.tju.edu
RTOG P-0011 has been updated as follows:
Section 5.3.2 —NCIC contact information has been updated to the following:
Ms. Suzan Moase
Intergroup Trials Associate
NCIC Clinical Trials Group
Queen's University
10 Stuart Street
Kingston, ON
Canada K7L 3N6
Phone: 613-533-6430
Fax: 613-533-2812
E-mail: smoase@ctg.queensu.ca
NOTE: This is an editorial/administrative change to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as “Update Date”.
An updated protocol is available (no password required) on the RTOG website: http://www.rtog.org/
SUMMARY OF CHANGES
Revision 2, Version Date: December 9, 2002
RTOG P-0011, PHASE III RANDOMIZED STUDY OF ADJUVANT THERAPY FOR HIGH RISK pT2-3N0 PROSTATE CANCER
Study Chair: Richard K. Valicenti, M.D., (215) 955-5936; FAX # (215) 955-0412; richard.valicenti@mail.tju.edu
IRB Review Requirements:
(X) Full board review required
( ) Expedited review allowed
( ) No review required
From July 2001 to August 2002, RTOG P-0011 accrued at a slower pace than expected with only 9 cases entered to the study. With the goal of 2850 cases unlikely to be reached within the originally projected five years, the Data Monitoring Committee (DMC) recommended adjusting the study design by dropping the androgen suppression only arm. The following sections have been revised for this change:
- Schema page — The date of closure of Arm 3 will be added upon CTEP approval of this revision; the sample size was revised.
- Section 1.0 — The last paragraph was added.
- Section 2.0 — Sections 2.1.1 and 2.2.1 were revised; Section 2.1.2 was deleted; Section 2.2.2 was added.
- Section 7.0 — References to “Arm 3” were removed from the heading and from Section 7.2.4; Section 7.1 was revised.
- Section 9.1 — In the last paragraph, the date of closure of Arm 3 will be added upon CTEP approval of this revision.
- Section 11.2.1 was revised to reflect the new study design.
- Sections 13.3.2, 13.4.1.1, 13.4.3.1, 13.4.4.1, 13.5.1, and 13.6.1 were added.
- Appendix I — The following sections of the sample consent were revised to reflect the dropping of the androgen suppression only arm: “Why Is This Study Being Done?”; “How Many People Will Take Part In The Study?”; “What Is Involved In The Study?”; and “How Long Will I Be In The Study?”.
Other Changes
Section 4.4 was revised to allow patients to have a pelvic MRI or CT scan; this change also was made in Section 11.1.
Section 10.0 — Section 10.1 was titled “Central Review” for clarity, and subsequent sections were renumbered appropriately; Section 10.1.3 (previously Section 10.2.1) was updated to RTOG standard.
Section 12.1 — The T8 data form was deleted as this form is not necessary for this study.
The following sections were revised by the Cancer Trials Support Unit for CTSU Investigators: Sections 5.2, 7.7, and 12.2; Section 10.5 was retitled; a note was added at the top of Appendix I.
A revised protocol is available (no password required) on the RTOG website: http://www.rtog.org/
SUMMARY OF CHANGES
Revision 1, June 10, 2002
RTOG P-0011, PHASE III RANDOMIZED STUDY OF ADJUVANT THERAPY FOR HIGH RISK pT2-3N0 PROSTATE CANCER
Study Chair: Richard K. Valicenti, M.D., (215) 955-5936; FAX # (215) 955-0412; richard.valicenti@mail.tju.edu
IRB Review Requirements:
(X) Full board review required
( ) Expedited review allowed
( ) No review required
RTOG P-0011 has been revised as follows:
Title Page
- The title was revised throughout the protocol to reflect the inclusion of T2 patients; this change in eligibility also was made to the Eligibility list on the Schema Page, page 1 of the Eligibility Checklist, to Sections 3.1.1.1 and 3.1.1.2, and Section 13.3.1 was added.
- The email address for Dr. Gomella, the study chair for Urology, was updated.
- NCIC has joined the study; the contact information for the NCIC study chair, Richard Choo, M.D., was added to the title page, and the following sections were added for NCIC Investigators: Sections 5.3, 7.8, 10.6, and 12.3.
Schema Page, Eligibility list — In the 2nd bullet, the risk of lymph node involvement was changed from “less than 5%” to “less than 15%”; this change also was made to number 7, page 1 of the Eligibility Checklist and to Sections 3.1.3, 4.5, and 11.1, footnote “d”.
Section 11.1 — “Rectal exam” was added to the table for clarification and to be consistent with Appendix I; in footnote “a”, the parenthetical reference to “Section 7.2.6” was corrected to “Section 11.2”.
Section 11.2.1 — The first and second sentences were revised for clarity.
Appendix I — Under “What Is Involved In The Study”, tests and procedures, the following changes were made so that the consent form corresponds to Sections 4.0 and 11.0:
- “Pelvic lymph node assessment” was added to procedures prior to study entry.
- “Physical exam - including rectal exam one month following the end of radiation therapy” was added.
- The schedule of the physical exam during hormonal therapy was corrected.
- The schedule of follow-up appointments was added for clarity.
Under “How Long Will I Be In The Study”, the fourth paragraph was revised for clarity.
CTSU requested revisions for CTSU Investigators in Sections 10.5 and 12.2.
A revised protocol is available (no password required) on the RTOG website:http://www.rtog.org/