Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Evaluate the progression-free survival of patients with locally advanced squamous cell
carcinoma of the head and neck treated with induction chemotherapy comprising
docetaxel, cisplatin, and fluorouracil followed by concurrent cetuximab and
- Assess the objective response rate in patients treated with this regimen.
- Assess the best overall response rate, overall survival, local-regional control, and
distant failure in patients treated with this regimen.
- Assess the acute and long-term toxicity associated with this regimen in these patients.
- Assess quality of life and swallowing in patients treated with this regimen.
- Determine the accuracy of PET/CT scan in evaluating objective response; in detecting
residual disease at primary sites and nodes; in guiding the recommendation for salvage
surgery or for neck dissection; and in early detection of recurrent or metastatic
OUTLINE: Patients are stratified according to nodal status (N2b-c or N3 vs N0-2a), tumor
characteristics of invasiveness (present vs absent), human papilloma virus (HPV) status
(positive vs negative), and primary tumor site (hypopharynx vs larynx vs oropharynx).
Patients receive induction chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV
over 1 hour on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3
weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Beginning 3-4 weeks after completion of induction chemotherapy, patients receive cetuximab
IV once weekly for 7 weeks. Beginning 1 week after the first dose of cetuximab, patients
undergo concurrent intensity-modulated radiotherapy or conventional 3-dimensional
radiotherapy once or twice daily 5-6 days a week for up to 6 weeks. Patients with persistent
disease undergo salvage resection of the primary tumor and/or neck dissection approximately
3 months after the completion of radiotherapy.
Patients undergo quality of life and swallowing evaluations periodically.
Patients undergo PET/CT scan at baseline, before beginning radiotherapy, at 6-8 weeks after
completion of study treatment, every 6 months for 5 years, and then annually thereafter.
After completion of study treatment, patients are followed at 4 and 8 weeks, every 2 months
for 2 years, every 3 months for 1 year, and then every 6 months thereafter.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Mercedes Porosnicu, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|