Testing Chemotherapy After Surgery for High-Risk Rectal Cancer With Blood Tumor DNA
Tests chemotherapy after surgery to stop rectal cancer returning in adults with tumor DNA.
Plain-language title generated from the registry record
Registry title: ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer
Key facts
- Where
- 'S-Gravenhage, 'S-Hertogenbosch, Almelo, Amersfoort, Amsterdam, Breda, Delft, Dordrecht, Eindhoven, Goes, Groningen, Hoorn Nh, Leeuwarden, Leiden, Nijmegen, Roosendaal, Rotterdam, Sneek, Terneuzen, Tilburg, and Uden, NetherlandsSee the 25 sites
- Phase
- Phase 3
Where in Netherlands
- Erasmus MCNetherlandsTaking people
- Haaglanden Medisch Centrum Stichting'S-Gravenhage, NetherlandsTaking people
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, NetherlandsTaking people
- Ziekenhuisgroep Twente StichtingAlmelo, NetherlandsTaking people
- Meander Medisch CentrumAmersfoort, NetherlandsTaking people
- Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
- Amphia HospitalBreda, NetherlandsTaking people
- Reinier de Graaf GroepDelft, NetherlandsTaking people
- Albert Schweitzer ZiekenhuisDordrecht, NetherlandsTaking people
- Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
- Admiraal De Ruyter Ziekenhuis B.V.Goes, NetherlandsTaking people
- Stichting Martini ZiekenhuisGroningen, NetherlandsTaking people
- Dijklander ZiekenhuisHoorn Nh, NetherlandsTaking people
- Frisius MCLeeuwarden, NetherlandsTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsTaking people
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
- Bravis ZiekenhuisRoosendaal, NetherlandsTaking people
- Ikazia ZiekenhuisRotterdam, NetherlandsTaking people
- Maasstad Ziekenhuis StichtingRotterdam, NetherlandsTaking people
- Sint Franciscus Vlietland Groep StichtingRotterdam, NetherlandsTaking people
- Antonius Ziekenhuis SneekSneek, NetherlandsTaking people
- ZorgSaam ZiekenhuisTerneuzen, NetherlandsTaking people
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, NetherlandsTaking people
- Bernhoven B.V.Uden, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Medical Center
- Trial code
- NCT07188025EU 2024-517700-12-00
- Record updated
- 2 October 2026
- Original 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.Read full original descriptionShow less
Adjuvant Chemotherapy for Prevention of Recurrence in Patients With Detectable ctDNA After Surgery in High-Risk Rectal Cancer
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.
Inclusion: 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: 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); 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; 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; Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another study interfering with the primary endpoint; Metastatic disease; History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance of the intervention group; Serious infections (uncontrolled or requiring treatment); Contra-indication for fluoropyrimidines or oxaliplatin; Pregnant and lactating women.