rectal cancer. rectal carcinoma.
Conditions
Interventions
Patients with detectable ctDNA after surgery and randomised to the experimental
group will be offered adjuvant chemotherapy within 8 weeks of surgery and no
longer than 12 weeks after surgery. Adjuv
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint The primary endpoint of the study will be disease-free survival in the intention-to-treat population, calculated from the date of surgery to the date of recurrence or death from any cause of the patient, whichever occurs first. The main analysis addressing the primary endpoint will be performed after 118 events, and is planned two years after the last included patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Secondary outcomes will be disease-free survival, carried out as per protocol analysis to analyse pure treatment effect. In addition, overall survival will be calculated measured from the date of surgery to the date of death from any cause. Quality of life will be assessed in both groups by obtaining questionnaires already provided by the PLCRC cohort study to compare the effect of adjuvant chemotherapy on quality of life. The robustness of ctDNA as biomarker will be analysed by comparing the disease-free survival of patients with detectable ctDNA who are not treated adjuvant chemotherapy (control group) with patients with undetectable ctDNA. | — |
Countries
Netherlands
Outcome results
None listed