Condition: Rectal Cancer · Sponsor: Erasmus Medical Center
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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 main research question the REACT study aims to answer is: \- Does adjuvant chemotherapy improve disease-free survival in patients with high-risk rectal cancer with detectable ctDNA after surgery? Interventions: \- Patients with detectable ctDNA after surgery and randomised to the experimental group will be offered adjuvant chemotherapy (4 cycles CAPOX/6 cycles FOLFOX) within 12 weeks after surgery.
This description comes directly from the study's public registry record.
Mirthe Ubink, MD · +31650162308 · REACT@erasmusmc.nl
Cornelis Verhoef, MD, PhD · 0031 10 704 1902
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch, Netherlands | Recruiting |
| Ziekenhuisgroep Twente | Almelo, Netherlands | Not Yet Recruiting |
| Meander Medisch Centrum | Amersfoort, Netherlands | Recruiting |
| Amsterdam UMC | Amsterdam, Netherlands | Not Yet Recruiting |
| Amphia | Breda, Netherlands | Recruiting |
| Reinier de Graaf Ziekenhuis | Delft, Netherlands | Recruiting |
| Albert Schweitzer Ziekenhuis | Dordrecht, Netherlands | Recruiting |
| Catharina Ziekenhuis | Eindhoven, Netherlands | Not Yet Recruiting |
| Admiraal De Ruyter Ziekenhuis | Goes, Netherlands | Recruiting |
| Martini Ziekenhuis | Groningen, Netherlands | Recruiting |
| Dijklander Ziekenhuis | Hoorn, Netherlands | Not Yet Recruiting |
| Frisius MC | Leeuwarden, Netherlands | Not Yet Recruiting |
+ 13 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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