A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
18 Years
N/A
Both
Head and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity
Trial Information
A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
OBJECTIVES:
- Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated
with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
- Correlate reduction of side effects on salivary flow with compliance in patients
treated with these regimens.
- Determine the rate of local-regional control, distant metastasis, and disease-free and
overall survival of patients treated with these regimens.
- Determine the acute and late toxicity of these regimens in these patients.
- Determine chemotherapy compliance in patients treated with these regimens.
OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for
approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or
unacceptable toxicity.
Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over
20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over
20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.
Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12
months after IMRT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
- WHO I-III
- No stage IVC disease
- No evidence of distant metastasis
- Measurable or evaluable disease
- Must have been treated with primary radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine no greater than 1.6 mg/dL
- Creatinine clearance at least 60 mL/min
Other
- Not pregnant*
- Negative pregnancy test*
- No other prior head and neck cancer
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No active untreated infection
- No other major medical or psychiatric illness that would preclude study entry
- Nutritional and general physical condition compatible with radiotherapy NOTE: *If
stage T2b or greater or node-positive disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 6 months since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 6 months since prior radiotherapy for head and neck cancer
Surgery
- No prior head and neck surgery to the primary tumor or lymph nodes except incisional
or excisional biopsies
Other
- No other concurrent experimental therapy for cancer
- No amifostine or pilocarpine during or for 3 months after radiotherapy
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Transportability of intensity-modulated radiotherapy technique in a multi0institytuibal setting
Principal Investigator
Nancy Lee, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000269314
NCT ID:
NCT00057785
Start Date:
February 2003
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Oral Complications of Radiation Therapy
- Radiation Toxicity
- oral complications of radiation therapy
- radiation toxicity
- stage I squamous cell carcinoma of the nasopharynx
- stage II squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
- Radiation Injuries
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
| McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| Albuquerque Regional Medical Center at Lovelace Sandia Health System | Albuquerque, New Mexico 87102 |
