ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adjuvant chemotherapy
Treatment groups
103 Participants
are divided into 2 treatment groupsSponsors and collaborators
Erasmus Medical Center
Lead sponsor
Prospectief Landelijk CRC Cohort (PLCRC)
Collaborator
Dutch Colorectal Cancer Group (DCCG)
Collaborator
BOOG Study Center
Collaborator
Source ClinicalTrials.gov