SUMMARY OF CHANGES
Update: February 5, 2008
(Broadcast on 2/5/08)
RTOG 0623, A Phase II Trial Of Combined Modality Therapy With Growth Factor Support
For Patients With Limited Stage Small Cell Lung Cancer
Study Chair: Rogerio Lilenbaum, MD; 305-535-3323; rlilenbaum@aptiumoncology.com
RTOG 0623 has been updated as follows:
Title page: The contact information for the CALGB Co-Chairs was deleted, as CALGB will not participate in this study.
Appendix I, the sample consent: In the second paragraph under "What are the costs of taking part in this study, the word, "vandetanib", was corrected to "filgrastim".
Note: This is an editorial/administrative change 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: January 15, 2008
(Broadcast 1/15/08)
RTOG 0623, A Phase II Trial Of Combined Modality Therapy With Growth Factor Support
For Patients With Limited Stage Small Cell Lung Cancer
Study Chair: Rogerio Lilenbaum, MD; 305-535-3323; rlilenbaum@aptiumoncology.com
RTOG 0623 has been updated as follows, as it is an IND exempt study:
Section 7.5: The IND number for filgrastim was deleted from the heading.
Section 7.5.6: The last sentence referring to the IND was deleted.
Note: This is an editorial/administrative change 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: January 8, 2008
RTOG 0623, A Phase II Trial Of Combined Modality Therapy With Growth Factor Support
For Patients With Limited Stage Small Cell Lung Cancer
Study Chair: Rogerio Lilenbaum, MD; 305-535-3323; rlilenbaum@aptiumoncology.com
RTOG 0623 has been updated as follows:
Section 5.1.1: In the first sentence, "QA" was added prior to "Center".
Section 6.1.1.3: In the first sentence, the phrase, "5 treatments", was clarified to "5 days of BID treatments".
Section 12.2 was updated to current RTOG standard.
Note: This is an editorial/administrative change 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.