ctDNA-guided adjuvant chemotherapy for high-risk rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial enrolls adults with high-risk rectal cancer who have detectable ctDNA post-surgery. Patients are randomized to receive adjuvant chemotherapy (CAPOX or FOLFOX) within 12 weeks after surgery. The study uses ctDNA status to identify those at higher risk of recurrence and to determine if additional systemic therapy improves disease-free survival. Primary outcomes focus on disease-free survival, with safety and treatment tolerability monitored. The trial is led by Erasmus Medical Center and involves national collaborators and multiple sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jeroen Bosch Ziekenhuis
  's-Hertogenbosch, Netherlands 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

Study contacts

• Principal investigator: Cornelis Verhoef, MD, PhD — Erasmus Medical Center
• Study coordinator: Mirthe Ubink, MD
• Email: REACT@erasmusmc.nl
• Phone: +31650162308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.