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DATE: March 15, 2010
SUBJECT: CALGB 30610/RTOG 0538, amendments: Further Important Information
Further important information for RTOG sites participating in CALGB 30610/RTOG 0538, "Phase III Comparison of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide", a CALGB-coordinated study:
RTOG previously broadcast CALGB's Update 4 on March 9th. Subsequently, CALGB provided the summaries of change for Updates 1-3, which are attached.
The current 30610/0538 protocol, which includes Updates 1-4, can be downloaded for IRB review by accessing the CTSU web site at www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). Click on the "Protocols" tab and search by Lead Organization or protocol number.
Per the RTOG Director of Regulatory Compliance, RTOG sites can submit Updates 1-4 of the study to their local IRBs within 90 days of this broadcast and will be in compliance. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Sites must submit IRB approval for the amendment to CTSU.
Please notify your affiliates that are not on e-mail.
If you have further questions regarding CALGB's protocol or updates, please contact the CALGB Protocol Coordinator, Colleen Watt, cboyle@uchicago.edu.
- 30610-0538 update 1 SOC.pdf
- 30610-0538 update 2 SOC.pdf
- 30610-0538 update 3 SOC.pdf
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DATE: March 9, 2010
SUBJECT: CALGB 30610/RTOG 0538, Amended
Amended
CALGB 30610/RTOG 0538, "Phase III Comparison Of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin And Etoposide", CALGB Update 4: Sections 6.3.1, 7.0, and 18 (model consent form) were amended.
Note: This is a CALGB-coordinated study in which RTOG is participating.
RTOG sites can download a copy of the protocol and update 4 for IRB review by accessing the CTSU web site at www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). Click on the "Protocols" tab and search by Lead Organization or protocol number.
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Sites must submit IRB approval for the amendment to CTSU.
Please notify your affiliates that are not on e-mail.
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DATE: March 25, 2008
SUBJECT: CALGB 30610/RTOG 0538: Activated
Activated
CALGB 30610/RTOG 0538, "Phase III Comparison Of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin And Etoposide"
Note: This is a CALGB-coordinated study in which RTOG is participating.
RTOG sites can download a copy of the protocol and forms for IRB review by accessing the CTSU web site at http://www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). CALGB-30610 is listed on the right.
Please notify your affiliates who are not on e-mail.
To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, http://www.rtog.org, under "Member Info," or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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