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Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical research trials and Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer  Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
For Condition: lip and oral cavity cancer,Head and Neck Cancer,Oropharyngeal Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Stanford University
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy. PURPOSE: Randomized phase II trial to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients who have stage III or stage IV head and neck cancer.
Details: OBJECTIVES: I. Compare the complete response rate following radiotherapy with or without tirapazamine (SR-4233) in patients with N1 squamous cell carcinoma of the head and neck. II. Compare the complete response rate to induction chemotherapy with cisplatin (CDDP) and fluorouracil (5-FU) with and without SR-4233 followed by concurrent CDDP/5-FU plus radiotherapy with and without SR-4233 in patients with N2 or N3 squamous cell carcinoma of the head and neck. III. Assess whether tumor hypoxia contributes to tumor resistance to treatment by measuring oxygen tension in cervical lymph node metastases and correlating these results with treatment response in both groups of patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to pO2 values (high vs low). Patients are randomized to one of two treatment arms. Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV continuously on days 1-5 and cisplatin IV over 4 hours on day 1. Treatment is repeated every 21 days for 2 courses. Patients who achieve at least partial response proceed to chemoradiotherapy consisting of cisplatin IV over 30-60 minutes, three times a week, during weeks 1 and 5. Patients also receive fluorouracil IV continuously for 4 days beginning on day 43 and again on day 71. Radiotherapy begins on day 43 (week 1) for 5.5 weeks. Patients with no response or progressive disease after induction chemotherapy proceed to salvage surgery. Arm II: Patients receive induction chemotherapy as in arm I plus tirapazamine IV over 1.0-2.5 hours prior to cisplatin. Patients proceed as in arm I. Those patients receiving chemoradiotherapy also receive tirapazamine IV on the same days as cisplatin. Some patients receive further radiotherapy and/or surgery. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over approximately 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 17 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Biopsy proven squamous cell carcinoma of the following head and neck sites: Hypopharynx; Oral cavity; Larynx; Oropharynx; Nasal cavity; Unknown primary; Paranasal sinus - Histologically proven poorly differentiated carcinoma of the following head and neck sites: Hypopharynx; Oral cavity; Larynx; Oropharynx; Nasal cavity; Paranasal sinus - Stage III/IV (T0-4 N1-3 M0-2) disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy to primary tumor allowed; No prior radiotherapy to site of metastatic neck disease - Surgery: Prior surgery allowed --Patient Characteristics-- - Age: Over 17 - Performance status: ECOG 0-2 - Hematopoietic: WBC at least 3,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; AST no greater than 100 U/L - Renal: Creatinine no greater than 2.0 mg/dL; Creatinine clearance at least 60 mL/min (patients in Group N2-N3) - Other: No second malignancy within 5 years except curatively treated nonmelanomatous skin carcinoma; Not pregnant or nursing; Negative pregnancy test required; Effective contraception required of fertile women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HarlanPinto, Study Chair, Stanford University
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Additional Information:
Study ID Numbers: CDR0000064752; SUMC-OP-003,NCI-T94-0119O
Study Start Date: February 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002774
Other Head And Neck Cancer Studies:
1. ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
2. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
3. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
4. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
5. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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