Status:
NOT_YET_RECRUITING
ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Prospectief Landelijk CRC Cohort (PLCRC)
Dutch Colorectal Cancer Group (DCCG)
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ma...
Detailed Description
Rationale - Rectal cancer is a worldwide cause of cancer related mortality. The incidence of rectal cancer in the Netherlands is approximately 3500 patients per year. The introduction of combined neoa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2035
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT07188025
Start Date
October 1 2025
End Date
October 1 2035
Last Update
September 23 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.