NCT01884259

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

Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Squamous Cell Carcinoma of the Hypopharynx Stage III
• Squamous Cell Carcinoma of the Hypopharynx Stage IV
• Squamous Cell Carcinoma of the Larynx Stage III
• Squamous Cell Carcinoma of the Larynx Stage IV
• Squamous Cell Carcinoma of the Oropharynx Stage III
• Squamous Cell Carcinoma of the Oropharynx Stage IV
• Squamous Cell Carcinoma of the Oral Cavity Stage III
• Squamous Cell Carcinoma of the Oral Cavity Stage IV

Interventions

Type	Name	Description
DRUG	Docetaxel	75 mg/m² on day 1 of 21-days cycle
DRUG	Cisplatin	75 mg/m² on day 1 of 21-days cycle
DRUG	5-fluorouracil	750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
BIOLOGICAL	Cetuximab Induction	weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
BIOLOGICAL	Cetuximab Radioimmunotherapy	weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
RADIATION	Boost irradiation	First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks

Timeline

• Start date: 2013-05-01
• Primary completion: 2021-01-28
• Completion: 2022-01-13
• First posted: 2013-06-24
• Last updated: 2022-05-26

Locations

8 sites across 1 country: Austria