Adjuvant chemotherapy for prevention of recurrence in patients with detectable ctDNA after surgery in high-risk rectal cancer.
- Conditions
- 10017991rectal cancer. rectal carcinoma.
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 206
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint<br /><br>The primary endpoint of the study will be disease-free survival in the<br /><br>intention-to-treat population, calculated from the date of surgery to the date<br /><br>of recurrence or death from any cause of the patient, whichever occurs first.<br /><br>The main analysis addressing the primary endpoint will be performed after 118<br /><br>events, and is planned two years after the last included patient.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br>Secondary outcomes will be disease-free survival, carried out as per protocol<br /><br>analysis to analyse pure treatment effect. In addition, overall survival will<br /><br>be calculated measured from the date of surgery to the date of death from any<br /><br>cause. Quality of life will be assessed in both groups by obtaining<br /><br>questionnaires already provided by the PLCRC cohort study to compare the effect<br /><br>of adjuvant chemotherapy on quality of life. The robustness of ctDNA as<br /><br>biomarker will be analysed by comparing the disease-free survival of patients<br /><br>with detectable ctDNA who are not treated adjuvant chemotherapy (control group)<br /><br>with patients with undetectable ctDNA.</p><br>