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Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer Clinical research trials and Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer  Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
For Condition: stage 3 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the larynx,stage 3 squamous cell carcinoma of the nasopharynx,Drug Toxicity,stage 3 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the nasopharynx,radiation toxicity,stage 3 squamous cell carcinoma of the lip and oral cavity,oral complications of cancer and cancer therapy
Status: Completed
Sponsor(s): William F. Bowld Hospital ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of treatment in patients receiving radiation therapy and cisplatin for advanced head and neck cancer.
Details: OBJECTIVES: I. Determine the efficacy of amifostine in alleviating treatment related mucositis associated with targeted supradose cisplatin and concurrent radiotherapy (RADPLAT protocol) in patients with stage III or IV squamous cell carcinoma of the head and neck. II. Determine the efficacy of amifostine in alleviating other treatment related morbidities associated with this protocol in these patients. PROTOCOL OUTLINE: This is an open label, multicenter study of amifostine. Patients receive external beam radiotherapy 5 days a week for approximately 6.5-7.5 weeks. Concurrent with radiotherapy, patients receive amifostine IV over 10 minutes, 30 minutes prior to cisplatin, then cisplatin intra-arterially over 3-5 minutes. Chemotherapy and amifostine course is repeated every week for 4 weeks. Patients are followed at 1 month. PROJECTED ACCRUAL: Approximately 30 patients will be accrued into this study over 12-18 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed squamous cell carcinoma of the oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx; Previously untreated Stage III or IV - No distant metastatic disease --Prior/Concurrent Therapy-- - No prior therapy for head and neck cancer - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: At least 24 hours since prior antihypertensive medication --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL; Creatinine clearance greater than 61 mL/min - Other: No history of any underlying medical or psychiatric illness; Not pregnant or nursing; Effective contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
K.Robbins, Study Chair, William F. Bowld Hospital
William F. Bowld Hospital
Memphis, Tennessee, 38103
United States
Additional Information:
Study ID Numbers: CDR0000066647; UTENN-6507,NCI-V98-1472,ALZA-98-066-ii
Study Start Date: June 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003580
Other Stage 4 Squamous Cell Carcinoma Of The Lip And Oral Cavity Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
2. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
3. Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
4. Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
5. Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
Related Studies:
Other stage 4 squamous cell carcinoma of the lip and oral cavity Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
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