Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN (HNO-2)

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Carcinoma of the Hypopharynx Stage IV; Squamous Cell Carcinoma of the Oropharynx Stage IV; Squamous Cell Carcinoma of the Hypopharynx Stage III; Squamous Cell Carcinoma of the Oral Cavity Stage IV; Squamous Cell Carcinoma of the Oral Cavity Stage III; Squamous Cell Carcinoma of the Oropharynx Stage III; Squamous Cell Carcinoma of the Larynx Stage IV; Squamous Cell Carcinoma of the Larynx Stage III

Treatments: Biological: Cetuximab Radioimmunotherapy; Drug: Cisplatin; Drug: 5-fluorouracil; Biological: Cetuximab Induction; Drug: Docetaxel; Radiation: Boost irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01884259

AGMT_HNO 2

Details and patient eligibility

About

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

Full description

It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV
• One measureable lesion (CT oder MR)
• Age 18 - 75 (including)
• Performance Score ECOG 0 - 1

Exclusion Criteria selected:

• Distant metastases
• ECOG Score >1
• Prior radiation (Head and neck area)
• Creatinin Clearance below 60 ml/µl
• Acute infections
• Neuropathy grade 3 or 4
• Myocardial Infarction within the last 12 months
• Acute coronary syndrome or othe clinically significant cardiovascular diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A

Active Comparator group

Description:

Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Active comparator is 5-fluorouracil for first three cycles.

Treatment:

Radiation: Boost irradiation

Drug: Cisplatin

Drug: Docetaxel

Drug: 5-fluorouracil

Biological: Cetuximab Radioimmunotherapy

B

Experimental group

Description:

All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Experimental: cetuximab for the first three cycles.

Treatment:

Radiation: Boost irradiation

Biological: Cetuximab Induction

Drug: Cisplatin

Drug: Docetaxel

Biological: Cetuximab Radioimmunotherapy