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

No results posted yet for this study

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

Cetuximab

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884623 on ClinicalTrials.gov