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Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC

NCT01864772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-08-19

No results posted yet for this study

Summary

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

Conditions

  • Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Interventions

DRUG

Carbo, 5FU, Cetuximab

6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2020-04-30
Completion
2020-05-26

Countries

  • France

Study Locations

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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 NCT01864772 on ClinicalTrials.gov