SUMMARY OF CHANGES
Update Date: May 22, 2008
(Broadcast 5/22/08)
RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer"
Study Chair: Jeffrey Bradley, M.D., 314-362-4633, jbradley@wustl.edu
RTOG 0617 has been updated as follows:
Section 10.0: The RTOG Tissue Bank has been renamed the RTOG Biospecimen Resource and has moved from LDS Hospital to the University of California San Francisco. This section was updated accordingly throughout. Appropriate changes were also made in Appendices V, VI and VII.
Section 10.4: The link to the RTOG Patient Tissue Consent Frequently Asked Questions was updated.
Section 10.5.4.2.2, letter f: Logistics for storage and shipping were corrected, per Appendix V. Buffy coat cryovials must be stored at -80 ºC (vs. -4ºC) until packed and shipped on dry ice (vs. ambient).
Appendix VII: CTSU registration hours were updated to 9 AM-5:30 PM EST.
Note: These are editorial/administrative changes to the protocol. NCI requires that these changes be documented on the protocol title page with the date of the update noted as "Update Date", not as an amendment.
SUMMARY OF CHANGES
Update Date: November 27, 2007
RTOG 0617, "A Randomized Phase III Comparison Of Standard- Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent And Consolidation Carboplatin/Paclitaxel In Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer"
Study Chair: Jeffrey Bradley, M.D., 314-362-4633, jbradley@wustl.edu
RTOG 0617 has been updated as follows:
The following changes were made to the Eligibility Checklist:
- Page 1, Question 1: The timeframe was corrected from 4 weeks to 12 weeks to be consistent with Section 3.1.1. No change was made to the study eligibility criteria.
- Page 3: Question 23 of this demographic portion of the checklist was made the last question, number 26, for purposes of programming for web registration. Subsequent questions were appropriately renumbered. No change was made to the study eligibility criteria.
Section 7.4: The phrase, "During Concurrent Therapy", was added to the heading for clarity.
Section 7.8: The study will use MedDRA, version 9.0 for grading of all adverse events. This information was added to the first sentence of the first paragraph.
Section 12.1: The timeframe for submission of the quality of life forms was corrected to be consistent with Section 11.2. The timeframe for these assessments also was corrected in Appendix II (table and footnote "g").
Appendix II: The pre-registration swallowing diary was indicated with an "X" to be consistent with Section 4.2.2. In the "Follow-Up" column, the phrase, "At 12 months only" was added for PFTs rather than the "X", for clarity.
Note: These are editorial/administrative changes to the protocol. NCI requires that these changes be documented on the protocol title page with the date of the update noted as "Update Date", not as an amendment.