MedTrace Logo

Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

NCT01427478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2021-06-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.

Conditions

Interventions

DRUG

AFATINIB

AFATINIBat the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months

DRUG

Placebo of AFATINIB

placebo of Afatinib at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months

Sponsors & Collaborators

Principal Investigators

  • Séverine RACADOT, MD · Centre Léon Bérard, Lyon

  • Pascal POMMIER, MD · Centre Léon Bérard, Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2020-11-30
Completion
2021-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01427478 on ClinicalTrials.gov