ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer

Sponsor
Erasmus Medical Center
Study ID
NCT07188025
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adjuvant chemotherapy — DRUG
    Adjuvant chemotherapy consists of 6 cycles of 5FU/folinic acid and oxaliplatin (FOLFOX) every 2 weeks, or 4 cycles of capecitabine and oxaliplatin (CAPOX). Duration of treatment will be 3 months (12 weeks).

Study Details

The goal of this clinical trial is to investigate whether adjuvant chemotherapy can prevent disease recurrence in patients with high-risk rectal cancer who have detectable ctDNA after surgery. The main research question the REACT study aims to answer is: \- Does adjuvant chemotherapy improve disease-free survival in patients with high-risk rectal cancer with detectable ctDNA after surgery? Interventions: \- Patients with detectable ctDNA after surgery and randomised to the experimental group will be offered adjuvant chemotherapy (4 cycles CAPOX/6 cycles FOLFOX) within 12 weeks after surgery.

Key Dates

First listed
Sep 23, 2025
Start date
Oct 14, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2035

Study Design

Enrollment
103 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care
    Control group ctDNA+
  • Experimental: Adjuvant chemotherapy
    Intervention group ctDNA+

Primary Outcome Measure

Disease-free survival, intention-to-treat [ Time Frame: Calculated from the date of surgery to the date of progression (recurrence) or death from any cause of the patient, whichever occurs first, assessed up to 2 years of follow-up ]

Central Contacts

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