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 groupsLocations
25Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
Ziekenhuisgroep Twente Almelo Netherlands
Meander Medisch Centrum Amersfoort Netherlands
Amsterdam UMC Amsterdam Netherlands
Sponsors 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