ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer (NCT07188025) | Clinical Trial Compass
RecruitingPhase 3
ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer
Netherlands103 participantsStarted 2025-10-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease-free survival, intention-to-treat
Timeframe: 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