|Subject: RTOG 1174 (OUTBACK), Amended
RTOG 1174 (ANZGOG 0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial” (Protocol, Group-Specific Study Handbook and Informed Consent)
· Section 8 (Treatment) has been updated to clarify dosing requirements and dose modifications;
· Section 9 (Summary of Assessment) has been updated to reflect that if a patient has had both a MRI of the pelvis and PET/CT at baseline, then a separate CT of the Chest/Abdo/Pelvis is not required; The timeframe for when baseline assessments should occur has been changed from within 4 weeks to within 6 weeks of randomization.
Group-Specific Study Handbook:
· Section 3.1 (Randomization), the screen shots for the InForm system have been updated to conform with updates to the InForm system
· Section 8 (SAE reporting) has been updated throughout to conform with updates to the InForm system
Group-Specific Informed Consent:
· Administrative changes for clarity made throughout
See the complete summary of changes for the amendment via the RTOG web site at
RTOG sites can download a copy of the Group-Specific Study Handbookon the RTOG website at
RTOG sites can download a copy of the Group-Specific Informed Consenton the RTOG website at
NCI policy requires that the "Version Date" on the Group-Specific Study Handbookand Group-Specific Informed Consent reflect the date the amendment was submitted to NCI
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days of this broadcast. RTOG recommends re-consenting patients per your local IRB policy. Sites must submit IRB approval for the amendments to CTSU.
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