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CHRONICLE: Chemotherapy or No Chemotherapy in Clear Margins After Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer
NCT00427713Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2004
- Primary completion
- Mar 2008
- Countries
- 1
- Sponsor
- Cancer Research UK
- Modality
- DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors, RNA-Targeting Small Molecules
- Conditions
- rectal cancer
01
Overview
Phase 3, randomised, open-label trial of capecitabine and oxaliplatin in rectal cancer (2 arms), sponsored by Cancer Research UK. Primary endpoint: Disease-free survival at 3 years. Started Nov 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard follow up
Patients undergo standard follow up.
Capecitabine + Oxaliplatin
Oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for up to 6 courses.
03
Who it enrols
Patients with histologically confirmed locally advanced adenocarcinoma of the rectum who underwent complete resection with clear margins after neoadjuvant chemoradiotherapy, with good performance status and adequate organ function.
04
Endpoints
Primary
Disease-free survival
Secondary
Overall survival
Toxicity
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