Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer
NCT01884623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2024-02-09
Summary
To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC. Efficacy assessed by failure free survival
Conditions
- Head Neck Cancer Squamous Cell Recurrent
Interventions
- DRUG
- DRUG
-
Methotrexate
Sponsors & Collaborators
-
National Cancer Institute, France
collaborator OTHER_GOV -
Ligue contre le cancer, France
collaborator OTHER -
Merck Serono International SA
collaborator INDUSTRY -
Gustave Roussy, Cancer Campus, Grand Paris
lead OTHER
Principal Investigators
-
Joel GUIGAY, Pr · Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-06
- Primary Completion
- 2021-10-12
- Completion
- 2021-10-12
Countries
- France
Study Locations
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