Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma, Squamous Cell

Frailty

Recurrence

Neoplasms, Squamous Cell

Carcinoma

Disease Attributes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Cetuximab

Fluorouracil

Antineoplastic Agents, Immunological

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

Carbo, 5FU, Cetuximab

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).

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

Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment

Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy

Best objective tumor response during treatment

Duration of response under cetuximab maintenance therapy

Toxicity of cetuximab maintenance therapy

Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment

Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC	NCT01864772	Metastatic or R...	Carbo, 5FU, Cet...	70 Years -	Groupe Oncologie Radiotherapie Tete et Cou
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC	NCT01864772	Metastatic or R...	Carbo, 5FU, Cet...	70 Years -	Groupe Oncologie Radiotherapie Tete et Cou
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC	NCT01864772	Metastatic or R...	Carbo, 5FU, Cet...	70 Years -	Groupe Oncologie Radiotherapie Tete et Cou

Spots Global Cancer Trial Database for carbo, 5fu, cetuximab