Who is sponsoring ELANFIT?

ELANFIT is sponsored by Groupe Oncologie Radiotherapie Tete et Cou.

What condition does ELANFIT study?

ELANFIT studies Metastatic or Recurrent Head and Neck Squamous Cell Cancer.

What drugs are being tested in ELANFIT?

Interventions: Carbo, 5FU, Cetuximab.

What is the status of ELANFIT?

ELANFIT is currently COMPLETED.

Last reviewed 2022-08-18 · How we verify

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 (ELANFIT)

NCT01864772 Phase 2 COMPLETED

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).

Details

Lead sponsor	Groupe Oncologie Radiotherapie Tete et Cou
Phase	Phase 2
Status	COMPLETED
Enrolment	85
Start date	2013-09
Completion	2020-05-26

Conditions

Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Interventions

Carbo, 5FU, Cetuximab

Primary outcomes

Objective response and acute toxicity — 1 month after the end of chemotherapy
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

Countries

France