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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Adjuvant chemotherapy
DrugAdjuvant chemotherapy consists of 6 cycles of 5FU/folinic acid and oxaliplatin (FOLFOX) every 2 weeks, or 4 cycles of capecitabine and oxaliplatin (CAPOX). Duration of treatment will be 3 months (12 weeks).
Treatment groups
103 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Adjuvant chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease-free survival, intention-to-treat
To investigate whether the disease-free survival in patients with rectal cancer who have detectable ctDNA after primary tumour resection, can be improved by administration of adjuvant chemotherapy.
Time frame
Calculated from the date of surgery to the date of progression (recurrence) or death from any cause of the patient, whichever occurs first, assessed up to 2 years of follow-upSecondary outcomes
1
Overall survival, intention-to-treat
To investigate whether overall survival of rectal cancer patients with detectable ctDNA after surgery can be improved with adjuvant chemotherapy
Time frame
From the date of surgery to the date of death from any cause of the patient, with a median follow-up of 5 years2
Disease-free survival, per-protocol
To compare all (eligible) patients in the control group to patients in the experimental group who actually started the adjuvant chemotherapy by a per protocol analysis (for pure treatment effect) for disease-free survival.
Time frame
Calculated from the date of surgery to the date of progression (recurrence) or death from any cause of the patient, assessed up to 2 years of follow-up3
Overall survival, per-protocol
To compare all (eligible) patients in the control group to patients in the experimental group who actually started the adjuvant chemotherapy by a per protocol analysis (for pure treatment effect) for overall survival.
Time frame
Calculated from the date of surgery to the date of death from any cause of the patient, with a median follow-up of 5 years4
The effect of adjuvant chemotherapy on quality of life - EQ-5D-5L
To compare the effect of adjuvant chemotherapy on quality of life - EQ-5D-5L
Time frame
Questionnaires are obtained within PLCRC at baseline, 3 months, 6 months, 1 year, 1.5 years, 2 years and yearly after, assessed up to 4 years of follow-upOther outcomes
1
The proportion of ctDNA-positive patients with specific mutational profiles.
To determine the mutational profile and ctDNA levels in ctDNA-positive patients.
Time frame
Assessed from the blood sample taken 14-28 days after rectal surgery.2
Correlations between ctDNA mutational profiles and clinical/pathological parameters and time to recurrence
To identify and analyse specific mutations detected in ctDNA and their correlation with clinical and pathological parameters, as well as time to recurrence.
Time frame
Assessed from the blood sample taken 14-28 days after rectal surgery.3
Concordance rate (%) between mutations identified in ctDNA and matched tumour tissue
To compare the mutational status of ctDNA with the mutational profile of available tumour tissue in patients, assessing concordance and potential discrepancies.
Time frame
Assessed from the blood sample taken 14-28 days after rectal surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Prospectief Landelijk CRC Cohort (PLCRC)
Collaborator
Dutch Colorectal Cancer Group
Collaborator
BOOG Study Center
Collaborator
Source ClinicalTrials.gov