NCT00868491

Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer

Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

Detailed description

The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head and neck are poor. In this proposed single-institution non-randomized, one-arm, open label phase II study, the authors will test the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck. Chemotherapy doses will be as follows: docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles followed by cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20, cisplatin 30 mg/m2 I.V. weeks 14-20. Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks {weeks 14 - 20}) will be used. The planned number of patients to be included is 30 and anticipated enrolment period is 12 months. The primary objective of the study is to determine locoregional control at 2 years post-therapy, whereas secondary objectives are to determine feasibility (toxicity profile) of the proposed regimen, to determine complete response rate after induction ChT as well as 14-16 weeks after the therapy, completion of ChRT to determine disease free survival at 2 years, overall survival at 2 years and late toxicity including thyroid function. Given the preliminary nature of the study, no stopping rule is prospectively planned outside of observed toxicity, which will be assessed and graded according to Common Terminology Criteria for Adverse Events version 3.0.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	docetaxel, cisplatin, 5-fluorouracil	docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles
RADIATION	radiotherapy	Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol
DRUG	cetuximab, cisplatin	* cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20 * cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2011-10-30
• First posted: 2009-03-25
• Last updated: 2024-10-18

Locations

1 site across 1 country: Slovenia