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.
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
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.
OBJECTIVES:
Primary
- 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.
Secondary
- Assess the disease-free interval and failure sites in patients treated with this
regimen.
- 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.
OUTLINE:
- 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
22-26.
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.
Inclusion Criteria:
- Patients must have a Karnofsky Performance Index ≥60%
- Patients must be over the age of 18.
- Patients must have a life expectancy of at least 6 months.
- Women of childbearing age must have a negative serum pregnancy test and agree to use
an effective method of contraceptive.
- Patients with a cardiac history should be cleared with a medical internist. In
general, patients with a history of prior bradyarrythmias, atrioventricular (AV)
conduction defects or marginal cardiac function will be eligible.
- Patients must have resectable stage III, stage IVA, stage IVB (without distant
metastases) squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
Hypopharyngeal carcinomas may also be stage II.
- Patients must not have had prior chemotherapy or radiotherapy (to the primary site or
nodes).
- Patients may not be planning to receive while on study concomitant immunotherapy or
hormonal therapy, except oral contraceptives or hormone replacement therapy.
- Patients must have adequate hepatic function documented by a normal serum bilirubin
0- 1.5mg/L and serum transaminases < 4 x upper limit.
- Patients must have adequate renal function documented by a serum creatinine not above
upper institutional normal limits and/or 24 hour OR calculated creatinine clearance
>60 ml/min. using the following formula:
(140-age) x Wt (kg) x .85 (if Estimated Creatinine Clearance = 72 x Creatinine
(mg/dl) female)
- Patients must have adequate bone marrow function documented by platelet count ≥
100,000 and absolute neutrophil count ≥ 2,000.
- Patients will have surgery according to Section 5.3. Operative and pathology reports
must be sufficiently detailed to confirm that surgery was done according to the
guidelines.
- Patients must be examined by a multi-modality team (consisting of a head and neck
surgeon, medical oncologist, and radiation oncologist) prior to entry on study.
- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines.
Exclusion Criteria:
- Distant metastases.
- Prior malignancy, except for adequately treated basal cell (or squamous cell) skin
cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for five years.
- Any condition that would be considered a contraindication for fluid challenge.
- Pregnant or lactating women may not participate.
- History of demyelinating neurological disorder, such as multiple sclerosis
- History of pancytopenia or aplastic anemia.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of treatment
Outcome Time Frame:
Up to one year
Safety Issue:
No
Principal Investigator
David E. Schuller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
OSU-06026
NCT ID:
NCT00566540
Start Date:
December 2007
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Ohio State University Medical Center | Columbus, Ohio 43210 |
