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ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer

NCT07188025 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-09-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Adjuvant chemotherapy

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).

Sponsors & Collaborators

  • Prospectief Landelijk CRC Cohort (PLCRC)

    collaborator UNKNOWN

  • Dutch Colorectal Cancer Group (DCCG)

    collaborator UNKNOWN

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Cornelis Verhoef, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2030-10-31
Completion
2035-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188025 on ClinicalTrials.gov