ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer
Recruiting · NCT07188025 · Interventional (participants receive a specific treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
25 locations listed.
- Jeroen Bosch Ziekenhuis - 's-Hertogenbosch, Netherlands
- Ziekenhuisgroep Twente - Almelo, Netherlands
- Meander Medisch Centrum - Amersfoort, Netherlands
- Amsterdam UMC - Amsterdam, Netherlands
- Amphia - Breda, Netherlands
- Reinier de Graaf Ziekenhuis - Delft, Netherlands
- Albert Schweitzer Ziekenhuis - Dordrecht, Netherlands
- Catharina Ziekenhuis - Eindhoven, Netherlands
- Admiraal De Ruyter Ziekenhuis - Goes, Netherlands
- Martini Ziekenhuis - Groningen, Netherlands
- Dijklander Ziekenhuis - Hoorn, Netherlands
- Frisius MC - Leeuwarden, Netherlands
- Leids Universitair Medisch Centrum (LUMC) - Leiden, Netherlands
- Canisius Wilhelmina Ziekenhuis - Nijmegen, Netherlands
- Radboud Universitair Medisch Centrum - Nijmegen, Netherlands
- Bravis Ziekenhuis - Roosendaal, Netherlands
- Erasmus MC - Rotterdam, Netherlands
- Franciscus - Rotterdam, Netherlands
- Ikazia Ziekenhuis - Rotterdam, Netherlands
- Maasstad Ziekenhuis - Rotterdam, Netherlands
- Antonius Ziekenhuis Sneek - Sneek, Netherlands
- ZorgSaam - Terneuzen, Netherlands
- Haaglanden Medisch Centrum - The Hague, Netherlands
- Elisabeth-Tweesteden Ziekenhuis - Tilburg, Netherlands
- Bernhoven - Uden, Netherlands