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Erlotinib,Radiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck

NCT00442455 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-06-06

No results posted yet for this study

Summary

The purpose of the study is to determinate the free-progression interval in patients with surgically resected locally advanced squamous cell carcinoma of head and neck treated with the maximum tolerated dose of the combination of erlotinib, radiation therapy and cisplatin, previously established in a safety trial.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Erlotinib chlorhydrate

150 mg/day for 7 weeks

DRUG

Cisplatin

30 mg/m2 i.v. weekly for 7 weeks

PROCEDURE

Radiation therapy

63 Gy, five days a week, for 7 weeks

Sponsors & Collaborators

  • Grupo de Investigación Clínica en Oncología Radioterapia

    lead OTHER

Principal Investigators

  • Felipe Calvo Manuel, Dr. · Hospital General Universitario Gregorio Marañón

  • Alejandro de la Torre Tomás, Dr. · Hospital Universitario Clínica Puerta de Hierro

  • Manuel de las Heras González, Dr. · Hospital San Carlos, Madrid

  • Ismael Herruzo Cabrera, Dr. · Hospital Regional Universitario Carlos Haya

  • Fernando Arias de la Vega, Dr. · Hospital de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT00442455 on ClinicalTrials.gov