RECRUITING Phase 3 ClinicalTrials.gov

ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer

Sponsor: Erasmus Medical Center • ClinicalTrials.gov ID: NCT07188025

Registry updated: 2026-10-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

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).

Eligibility criteria

Inclusion Criteria * Detectable ctDNA in the postoperative blood sample * Age ≥ 18 years * WHO performance score 0-1 * Informed consent for PLCRC with specific consent for additional blood withdrawals and offering of future experimental research * Informed consent for the REACT trial. * Histological confirmed rectal cancer; either treated with neoadjuvant (chemo)radiotherapy, and/or clinical/pathological T3/T4 and/or N+ in case no neoadjuvant therapy was administered. * Eligible to receive treatment with combination adjuvant chemotherapy (CAPOX/FOLFOX) according to the treating physician. * Mentally competent and able to read and understand Dutch language. Exclusion Criteria: * Metastatic disease * Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma * Incomplete primary tumour resection (R1 or R2 resection) * Contra-indication for fluoropyrimidines or oxaliplatin * Neoadjuvant oxaliplatin based systemic treatment, e.g. treated with the RAPIDO regimen consisting of short course radiotherapy followed by 6 cycles of CAPOX or 9 cycles of FOLFOX prior to surgery * Patients with a clinical complete response, who will not undergo surgery. * Pregnant and lactating women * History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance of the intervention group * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator * Serious infections (uncontrolled or requiring treatment) * Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another study interfering with the primary endpoint.

Conditions

Rectal Cancer

Locations

Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands
Ziekenhuisgroep Twente — Almelo, Netherlands
Meander Medisch Centrum — Amersfoort, Netherlands
Amsterdam UMC — Amsterdam, Netherlands
Amphia — Breda, Netherlands
Reinier de Graaf Ziekenhuis — Delft, Netherlands
Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands
Catharina Ziekenhuis — Eindhoven, Netherlands
Admiraal De Ruyter Ziekenhuis — Goes, Netherlands
Martini Ziekenhuis — Groningen, Netherlands
Dijklander Ziekenhuis — Hoorn, Netherlands
Frisius MC — Leeuwarden, Netherlands
Leids Universitair Medisch Centrum (LUMC) — Leiden, Netherlands
Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands
Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
Bravis Ziekenhuis — Roosendaal, Netherlands
Erasmus MC — Rotterdam, Netherlands
Franciscus — Rotterdam, Netherlands
Ikazia Ziekenhuis — Rotterdam, Netherlands
Maasstad Ziekenhuis — Rotterdam, Netherlands
Antonius Ziekenhuis Sneek — Sneek, Netherlands
ZorgSaam — Terneuzen, Netherlands
Haaglanden Medisch Centrum — The Hague, Netherlands
Elisabeth-Tweesteden Ziekenhuis — Tilburg, Netherlands
Bernhoven — Uden, Netherlands

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment