Trials / Completed
CompletedNCT02404935
Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 139 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cetuximab | |
| DRUG | FOLFIRI and cetuximab |
Timeline
- Start date
- 2013-11-22
- Primary completion
- 2020-11-01
- Completion
- 2021-10-25
- First posted
- 2015-04-01
- Last updated
- 2022-03-24
Locations
47 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02404935. Inclusion in this directory is not an endorsement.