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Adjuvant Chemotherapy in High-Risk Rectal Cancer With Detectable ctDNA After Surgery
NCT07188025Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- Oct 2030
- Countries
- 1
- Sponsor
- Erasmus MC
- Modality
- DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors, RNA-Targeting Small Molecules
- Conditions
- rectal cancer
01
Overview
Phase 3, randomised, open-label trial of fluorouracil, folinic acid, oxaliplatin and capecitabine in rectal cancer (2 arms), sponsored by Erasmus MC. Primary endpoint: Disease-free survival, intention-to-treat up to 2 years. Started Oct 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard of Care
Control group ctDNA+
Adjuvant chemotherapy
Intervention group ctDNA+ receiving FOLFOX or CAPOX
03
Who it enrols
Adult patients with histologically confirmed rectal cancer who have undergone surgery and have detectable ctDNA in the postoperative blood sample, with an ECOG performance status of 0-1, and no metastatic disease or prior neoadjuvant oxaliplatin-based systemic treatment.
04
Endpoints
Primary
Disease-free survival, intention-to-treat
Secondary
Overall survival, intention-to-treat
Disease-free survival, per-protocol
Overall survival, per-protocol
The effect of adjuvant chemotherapy on quality of life - EQ-5D-5L
The effect of adjuvant chemotherapy on quality of life - QLQ-C30
The effect of adjuvant chemotherapy on quality of life - QLQ-CR29
Comparing disease-free survival of patients with detectable ctDNA but without receiving adjuvant chemotherapy with patients with undetectable ctDNA
Comparing overall survival of patients with detectable ctDNA but without receiving adjuvant chemotherapy with patients with undetectable ctDNA
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