Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial (ASOG-HNO1)

Austrian South Oncology Group

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Radiation: Radiotherapy; Drug: Docetaxel; Drug: Cisplatin; Drug: 5-FU; Drug: Cetuximab

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT00502463

AGMT_HNO

Details and patient eligibility

About

The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV

Full description

3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;

Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed, locally advanced head and neck cancer
• stage III/IV
• performance status: ECOG 0-1

Exclusion criteria

• distant metastases
• prior radiotherapy of the head and neck region
• myocardial infarct in the last six months
• florid peptic ulcer
• neuropathy grade III/IV

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Single Arm

Experimental group

Description:

3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab

Treatment:

Drug: Docetaxel

Drug: Cisplatin

Radiation: Radiotherapy

Drug: 5-FU

Drug: Cetuximab