Adjuvant chemotherapy for prevention of recurrence in patients with detectable ctDNA after surgery in high-riskrectal cancer.

Phase 3

Not yet recruiting

Conditions: Rectal cancer

Registration Number: 2024-517700-12-00

Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 103

Inclusion Criteria

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 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

Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma

Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study.

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 surger

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)