ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer
Recruiting now · Phase 3
Conditions studied: Rectal Cancer
In brief
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 facts
- Study ID
- NCT07188025
- Run by
- Erasmus Medical Center
- People needed
- 103
- Starts
- 2025-10-14
- Expected to finish
- 2035-10-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Bravis Ziekenhuis — Roosendaal, Netherlands (enrolling)
- Erasmus MC — Rotterdam, Netherlands (enrolling)
- Franciscus — Rotterdam, Netherlands (enrolling)
- Ikazia Ziekenhuis — Rotterdam, Netherlands (enrolling)
- Maasstad Ziekenhuis — Rotterdam, Netherlands (enrolling)
- Admiraal De Ruyter Ziekenhuis — Goes, Netherlands (enrolling)
- ZorgSaam — Terneuzen, Netherlands (enrolling)
- Martini Ziekenhuis — Groningen, Netherlands (enrolling)
- Elisabeth-Tweesteden Ziekenhuis — Tilburg, Netherlands (enrolling)
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (enrolling)
- Amphia — Breda, Netherlands (enrolling)
- Reinier de Graaf Ziekenhuis — Delft, Netherlands (enrolling)
- Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands (enrolling)
- Meander Medisch Centrum — Amersfoort, Netherlands (enrolling)
- Radboud Universitair Medisch Centrum — Nijmegen, Netherlands (enrolling)
- Bernhoven — Uden, Netherlands
- Ziekenhuisgroep Twente — Almelo, Netherlands
- Amsterdam UMC — Amsterdam, Netherlands
- Catharina Ziekenhuis — Eindhoven, Netherlands
- Dijklander Ziekenhuis — Hoorn, Netherlands
- Frisius MC — Leeuwarden, Netherlands
- Leids Universitair Medisch Centrum (LUMC) — Leiden, Netherlands
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands
- Antonius Ziekenhuis Sneek — Sneek, Netherlands
- Haaglanden Medisch Centrum — The Hague, Netherlands
Full record on ClinicalTrials.gov
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