Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
locoregional control
at 2 years post-therapy
No
Primož Strojan, MD
Principal Investigator
Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia
Slovenia: Ethics Committee
EMR-62202-717
NCT00868491
March 2008
October 2011
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