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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer  Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
For Condition: radiation toxicity,oral complications of chemotherapy and head/neck radiation,stage 2 squamous cell carcinoma of the nasopharynx,stage 3 squamous cell carcinoma of the nasopharynx,stage 1 squamous cell carcinoma of the nasopharynx,stage 4 squamous cell carcinoma of the nasopharynx
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 - Not specified 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NancyLee, Study Chair, Memorial Sloan-Kettering Cancer Center
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Contact Person 414-805-4450
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Additional Information:
Study ID Numbers: CDR0000269314; RTOG-0225
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057785
Other Radiation Toxicity Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx
2. Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
3. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
4. High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer
5. Radiation Therapy Alone Compared to Radiation Therapy Plus Chemotherapy in Treating Patients With Previously Untreated Cancer of the Nasopharynx
Related Studies:
Other radiation toxicity Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
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