Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

Phase 2

Completed

Conditions: Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity

Interventions: Drug: cisplatin
Drug: fluorouracil
Radiation: Intensity modulated radiation therapy

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.

Detailed Description: OBJECTIVES:

* Determine the transportability of IMRT to a multi-institutional setting.

* 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
IMRT +/- chemotherapy	cisplatin	Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
IMRT +/- chemotherapy	Intensity modulated radiation therapy	Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
IMRT +/- chemotherapy	fluorouracil	Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Primary Outcome Measures

Name	Time	Method
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered	From start of treatment to end of treatment	Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.

Secondary Outcome Measures

Name	Time	Method
Rate of Xerostomia at 1 Year (Grade ≥ 2)	From start of treatment to 1 year
Rate of Locoregional Control at 2 Years	From registration to 2 years
Whole Mouth Saliva Output Relative to Pretreatment Measurements	From start of treatment to 1 year
Other Acute and Late Toxicities	From start of treatment to last follow-up
Chemotherapy Compliance	From start of treatment to end of treatment

Locations (17): Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸
St Louis, Missouri, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸
Sacramento, California, United States
Wilford Hall Medical Center
🇺🇸
Lackland AFB, Texas, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
UCSF Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Northeast Georgia Medical Center
🇺🇸
Gainesville, Georgia, United States
Albuquerque Regional Medical Center at Lovelace Sandia Health System
🇺🇸
Albuquerque, New Mexico, United States
McKay-Dee Hospital Center
🇺🇸
Ogden, Utah, United States
Akron City Hospital
🇺🇸
Akron, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Fox Chase-Temple Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸
Houston, Texas, United States
University of California Davis Cancer Center
🇺🇸
Davis, California, United States
Monmouth Medical Center
🇺🇸
Long Branch, New Jersey, United States
CCOP - MainLine Health
🇺🇸
Wynnewood, Pennsylvania, United States
Medical College of Wisconsin Cancer Center
🇺🇸
Milwaukee, Wisconsin, United States