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Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer
NCT04643366Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2021
- Primary completion
- Jan 2030
- Countries
- 1
- Sponsor
- Virginia Commonwealth University
- Modality
- DNA Intercalators/Alkylators, Orthosteric Ligands
- Conditions
- rectal cancer
01
Overview
Phase 2, open-label, single-arm trial of fluorouracil, folinic acid and oxaliplatin in rectal cancer, sponsored by Virginia Commonwealth University. Primary endpoint: Disease-Free Survival at 3 years. Started Jan 2021; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Concurrent Chemotherapy/ Radiation Therapy
mFOLFOX6 -> IMRT + 5-FU -> mFOLFOX6 -> Surgery/Surveillance
03
Who it enrols
Adults with resectable rectal cancer (T3-4 N0 M0 or T any N1-2 M0), ECOG <= 2, adequate organ function, no prior RT or significant cardiac/pulmonary disease.
04
Endpoints
Primary
Disease-Free Survival
Secondary
Pathologic Complete Response
Clinical Complete Response
Adverse Events
Progression-Free Survival
Overall Survival
Number of patients who do not require an ostomy at time of surgery
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