Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, and Hypopharynx: Incorporation of Intensity Modulated Radiotherapy and Submandibular Gland Transfer to Minimize Treatment Morbidity; Correlative Imaging/Molecular Markers.
- Determine the feasibility of a new intensification regimen comprising cisplatin and
paclitaxel in combination with radiotherapy and surgery in patients with resectable
advanced squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
- Assess the disease-free interval and failure sites in patients treated with this
- Correlate molecular markers with treatment outcome in these patients.
- Correlate quality of life with treatment outcome in these patients.
- Determine the frequency and severity of toxicities of this regimen in these patients.
- Evaluate treatment completion in these patients.
- Preoperative therapy (weeks 1 and 2): Patients receive cisplatin IV over 2 hours on
days 1-3. Patients also undergo intensity-modulated external beam radiotherapy once
daily on days 1-5 and 8-12.
- Surgery (week 3): Patients undergo surgical resection of the primary tumor (with or
without neck dissection) and intraoperative boost radiotherapy.
- Postoperative therapy (weeks 7-10): Patients receive cisplatin IV over 2 hours on days
1-3 and 22-24 and paclitaxel IV over 3 hours on days 1, 8, 15, and 22. Patients also
undergo intensity-modulated external beam radiotherapy on days 1-5, 8-12, 15-19, and
Patients undergo blood and tissue sample collection at baseline, in weeks 3, 7-10, and 14,
and then periodically thereafter for biomarker correlative studies.
Quality of life is assessed at baseline, at 3, 6, and 12 months after completion of
treatment, and then annually thereafter.
After completion of study treatment, patients are followed every 2 months for 1 year and
then periodically thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of treatment
Up to one year
David E. Schuller, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|