Trials / Unknown
UnknownNCT05362617
mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy
mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy（NEW RECHALLENGE）- A Multicenter Open Prospective Randomized Controlled Trial
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 328 (estimated)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter,open,prospective randomized controlled trial;11 study center in China; Plan to enroll 328 patients（ Power Analysis and Sample Size ）.Comparing FOLFIRI with mFOLFOX6,Superiority design.Investigate difference PFS,ORR,R0 resection rate,OS ,QoL and Safety from two regimens Stratification factors : Analyzing patients recurrence within 6-12months,and 12-18months .Obtain definite chemotherapy regimen shift opportunity for patients recurrence/metastasis after adjuvant chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FOLFIRI | FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2022-12-31
- Completion
- 2023-12-31
- First posted
- 2022-05-05
- Last updated
- 2022-05-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05362617. Inclusion in this directory is not an endorsement.