Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
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.
Head and Neck Cancer
Oral Complications of Radiation Therapy
Procedure: adjuvant therapy
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer|
- Protocol compliance of Intensity-modulated radiotherapy treatment delivered [ Time Frame: From start of treatment to end of treatment ] [ Designated as safety issue: No ]
- Rate of xerostomia at 1 year (grade ≥ 2) [ Time Frame: From start of treatment to 1 year ] [ Designated as safety issue: Yes ]
- Rate of locoregional control at 2 years [ Time Frame: From registration to 2 years ] [ Designated as safety issue: No ]
- Whole mouth saliva output relative to pretreatment measurements [ Time Frame: From start of treatment to 1 year ] [ Designated as safety issue: No ]
- Other acute and late toxicities [ Time Frame: From start of treatment to last follow-up ] [ Designated as safety issue: Yes ]
- Chemotherapy compliance [ Time Frame: From start of treatment to end of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Intensity modulated radiation therapy +/- chemotherapy
Intensity modulated radiation therapy (IMRT) +/- chemotherapy
|Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: assessment of therapy complications Procedure: quality-of-life assessment Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057785
|United States, Alabama|
|Comprehensive Cancer Center at University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California Davis Cancer Center|
|Davis, California, United States, 95616|
|Radiological Associates of Sacramento Medical Group, Incorporated|
|Sacramento, California, United States, 95815|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Georgia|
|Northeast Georgia Medical Center|
|Gainesville, Georgia, United States, 30501|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|St Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Monmouth Medical Center|
|Long Branch, New Jersey, United States, 07740|
|United States, New Mexico|
|Albuquerque Regional Medical Center at Lovelace Sandia Health System|
|Albuquerque, New Mexico, United States, 87102|
|United States, Ohio|
|Akron City Hospital|
|Akron, Ohio, United States, 44304|
|United States, Pennsylvania|
|Fox Chase-Temple Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107|
|CCOP - MainLine Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030|
|Wilford Hall Medical Center|
|Lackland AFB, Texas, United States, 78236|
|United States, Utah|
|McKay-Dee Hospital Center|
|Ogden, Utah, United States, 84403|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Nancy Lee, MD||Memorial Sloan-Kettering Cancer Center|