Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mFOLFOX6 3-6 month · 1 trial · 1 indication
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 from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).
| Arm | Type | Description |
|---|---|---|
| Cohort A - Arm 1 (ctDNA-ve) | ACTIVE_COMPARATOR | Oxaliplatin 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 OR Oxaliplatin 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 |
| Cohort A - Arm 2 (ctDNA-ve) | EXPERIMENTAL | Serial ctDNA monitoring no treatment |
| Cohort B - Arm 3 (ctDNA+ve) | ACTIVE_COMPARATOR | Oxaliplatin 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 OR Oxaliplatin 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 |
| Cohort B - Arm 4 (ctDNA+ve) | EXPERIMENTAL | Oxaliplatin 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 |
| Name | Type | Description |
|---|---|---|
| Signatera test | DEVICE | Central ctDNA testing for all patients |
| mFOLFOX6 3-6 month | DRUG | Oxaliplatin 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 | DRUG | Oxaliplatin 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 | DRUG | Oxaliplatin 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 | DRUG | Oxaliplatin 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 | DRUG | Oxaliplatin 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 |
Inclusion Criteria: The patient must have an ECOG performance status of 0 or 1. Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria. No radiographic evidence of overt metastatic disea...
mFOLFOX6 3-6 month is an investigational chemotherapy regimen being studied for the treatment of Stage III Colon Cancer. It is a small molecule therapy currently in Phase 2 clinical development, evaluated in the adjuvant setting to assess its efficacy based on residual disease evaluation.
mFOLFOX6 3-6 month is being developed by Natera, Inc., a company traded on the NASDAQ under the ticker symbol NTRA. The company is conducting a Phase 2 clinical trial to evaluate this chemotherapy regimen in patients with Stage III Colon Cancer.
mFOLFOX6 3-6 month is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of Stage III Colon Cancer.
mFOLFOX6 3-6 month is being evaluated in a single Phase 2 clinical trial with the identifier NCT05174169, titled 'Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease.' The trial is actively recruiting participants in the United States, Canada, and Puerto Rico, with a planned enrollment of 1912 patients.
Yes, the clinical trial for mFOLFOX6 3-6 month is randomized and active-controlled. The study is not double-blinded, meaning both researchers and participants know which treatment is being administered. The trial enrolls adults aged 18 years and older, including both males and females.