Ireland
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Recruiting Phase 3

ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer

NCT07188025 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 3
Started
2025-10-14
Last updated
2026-10-02

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Adjuvant chemotherapy

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).

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Disease-free survival, intention-to-treat — 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
    To investigate whether the disease-free survival in patients with rectal cancer who have detectable ctDNA after primary tumour resection, can be improved by administration of adjuvant chemotherapy.

Trial sites (25)

FacilityCityRegionStatus
Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands Recruiting
Ziekenhuisgroep Twente Almelo Netherlands Not Yet Recruiting
Meander Medisch Centrum Amersfoort Netherlands Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
Amphia Breda Netherlands Recruiting
Reinier de Graaf Ziekenhuis Delft Netherlands Recruiting
Albert Schweitzer Ziekenhuis Dordrecht Netherlands Recruiting
Catharina Ziekenhuis Eindhoven Netherlands Recruiting
Admiraal De Ruyter Ziekenhuis Goes Netherlands Recruiting
Martini Ziekenhuis Groningen Netherlands Recruiting
Dijklander Ziekenhuis Hoorn Netherlands Not Yet Recruiting
Frisius MC Leeuwarden Netherlands Not Yet Recruiting
Leids Universitair Medisch Centrum (LUMC) Leiden Netherlands Not Yet Recruiting
Canisius Wilhelmina Ziekenhuis Nijmegen Netherlands Not Yet Recruiting
Radboud Universitair Medisch Centrum Nijmegen Netherlands Recruiting
Bravis Ziekenhuis Roosendaal Netherlands Recruiting
Erasmus MC Rotterdam Netherlands Recruiting
Franciscus Rotterdam Netherlands Recruiting
Ikazia Ziekenhuis Rotterdam Netherlands Recruiting
Maasstad Ziekenhuis Rotterdam Netherlands Recruiting
Antonius Ziekenhuis Sneek Sneek Netherlands Recruiting
ZorgSaam Terneuzen Netherlands Recruiting
Haaglanden Medisch Centrum The Hague Netherlands Recruiting
Elisabeth-Tweesteden Ziekenhuis Tilburg Netherlands Recruiting
Bernhoven Uden Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07188025 on ClinicalTrials.gov ↗ ← All trials in the Netherlands