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DATE: August 10, 2007
SUBJECT: RTOG 0123, Closure
Closure
RTOG 0123, "A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer", will close to patient accrual at 5 PM EST today, as the study has not met its accrual objective. Notice of this closure was previously broadcast on July 30, 2007.
Please notify your affiliates that 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, 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 or 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 available at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: July 30, 2007
SUBJECT: RTOG 0123, Closure Notice
Closure Notice
RTOG 0123, "A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer", will close to patient accrual at 5 PM EST on Friday, August 10th due to accrual problems.
Please notify your affiliates that 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, 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 or 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 available at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: May 25, 2006
Amended
RTOG 0123, "A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer", Amendment 3: In order to make the study available to more patients, the required timeframes or registering patients and for pre-randomized evaluations were amended. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0123/summary_changes.html
Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0123/0123.pdf
NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses.
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence.
Please notify your affiliates that 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, 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 David Corrie at dcorrie@acr-arrs.org.
Web registration is available 24/7. Information and instructions available at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: February 3, 2005
SUBJECT: RTOG 0123, Amended
Amended
RTOG 0123, “A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer”, Amendment #2: The timeframe for registration and randomization was amended, and instructions regarding hypotensive episodes were added to Section 7.3. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0123/summary_changes.html
You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0123/0123.pdf
NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses.
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence.
To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, 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 David Corrie at dcorrie@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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DATE: January 13, 2004
SUBJECT: PROTOCOL NOTICE: RTOG 0123, Revised
Revised
RTOG 0123, “A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer”, Revision #1: Instructions for discontinuing captopril for pulmonary toxicity were added to Section 7.4.2, and revisions for clarity were made to the Schema and Sections 3, 11, and 12. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0123/summary_changes.html
Regulatory Notes: NCI policy requires that the “Version Date” of the protocol reflect the date the revision was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses next to the version date.
You may download a copy of the protocol for IRB review by accessing the RTOG Web site at http://www.rtog.org/members/protocols/0123/0123.pdf When submitting this revision to your IRB (Expedited review is allowed; however, site IRB requirements take precedence), please identify the revision as #1 (12/16/03). After you receive IRB approval of the revision, please fax the approval to the CTSU Regulatory Office at 215-569-0206.
If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org
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