Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
ConditionStage III Colon Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology
About this trial
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
Platelet count must be greater than or equal to 100,000/mm3; and
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Signatera test
DeviceCentral ctDNA testing for all patients
mFOLFOX6 3-6 month
DrugOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles
CAPOX 3 month
DrugOxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles
mFOLFIRINOX
DrugOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
mFOLFOX6 6 month
DrugOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
CAPOX 6 month
DrugOxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles
Treatment groups
1,912 Participants
are divided into 4 treatment groupsGroup A: Cohort A - Arm 1 (ctDNA-ve)Active comparator 3 interventions
Group B: Cohort A - Arm 2 (ctDNA-ve)Experimental treatment 1 intervention
Group C: Cohort B - Arm 3 (ctDNA+ve)Active comparator 3 interventions
Group D: Cohort B - Arm 4 (ctDNA+ve)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
ctDNA positive status (TTPos)
TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.
Time frame
Time from randomization to the first TTPos event, a maximum of 3 years2
Disease-Free Survival (DFS)
Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).
Time frame
Time from randomization to disease-free survival event, a maximum of 5 years]Secondary outcomes
1
Baseline post-surgery ctDNA positivity rate
percentage of patients with ctDNA positive results post-surgery at study entry.
Time frame
At time of randomization2
Overall Survival (OS)
Time from randomization to death of any cause.
Time frame
Time from randomization to death, a maximum of 5 years.3
Recurrence
Time from randomization to disease recurrence.
Time frame
Time from randomization to disease recurrence, a maximum of 5 years4
Compliance with adjuvant chemotherapy
number of cycles of chemotherapy received.
Time frame
from randomization to the last cycle of chemotherapy, a maximum of 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov