Fluorouracil for Rectal cancer

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- WHO performance score 0-1\n- Informed consent for PLCRC with specific consent for additional blood withdrawals and offering of future experimental research\n- Informed consent for the REACT trial\n- Histological confirmed rectal cancer; either treated with neoadjuvant (chemo)radiotherapy, and/or clinical T4 and/or N+ in case no neoadjuvant therapy was administered\n- Eligible to receive treatment with combination adjuvant chemotherapy (CAPOX/FOLFOX) according to the treating physician.\n- Mentally competent and able to read and understand Dutch language.\n- Detectable ctDNA in the postoperative blood sample"}

Exclusion criteria

• {"criterion_text":"- Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma\n- Serious infections (uncontrolled or requiring treatment)\n- Metastatic disease\n- Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study.\n- Incomplete primary tumour resection (R1 or R2 resection)\n- Contra-indication for fluoropyrimidines or oxaliplatin\n- 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\n- Patients with a clinical complete response, who will not undergo surger\n- Pregnant and lactating women\n- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance of the intervention group\n- 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"}

Primary endpoints

• {"endpoint_text":"- disease-free survival in the intention-to-treat population","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Disease-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life","definition_or_measurement_approach":""}
• {"endpoint_text":"- In addition to intention-to-treat analysis to estimate the effect size, also a per-protocol analysis (for pure treatment effect) will be carried out for disease-free survival and overall survival","definition_or_measurement_approach":"Per-protocol analysis will be performed in addition to intention-to-treat to estimate pure treatment effect for disease-free survival and overall survival."}
• {"endpoint_text":"- The results of the ctDNA analysis of the blood samples taken at the first follow-up of the randomised patients who were ctDNA positive after surgery will be compared between the patients who received adjuvant chemotherapy and those who did not.","definition_or_measurement_approach":"Comparison of ctDNA analysis results from blood samples taken at first follow-up between treated and untreated randomized patients who were ctDNA positive after surgery."}
• {"endpoint_text":"- Within the group of patients with de-tectable ctDNA after surgery, the pro-portion of patients with detectable ctDNA in the peripheral blood at the timing of detection of recurrent dis-ease on imaging will be assessed.","definition_or_measurement_approach":"Proportion of patients with detectable ctDNA in peripheral blood at the time recurrent disease is detected on imaging will be assessed."}

Methods

• Recruitment from the PLCRC prospective cohort/registry (inclusion requires informed consent for PLCRC and specific consent for additional blood withdrawals).
• Site-based recruitment at participating hospitals/centres in the Netherlands (local clinics and surgical/oncology departments listed as trial sites).

Netherlands

Earliest CTIS Part Ii Submission Date

08-10-2024

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

469

Number Of Sites

19

Number Of Participants

103

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands