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Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer Clinical research trials and Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer. Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer clinical trial. Subjects frequently get the best healthcare possible for their Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer  Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
For Condition: Throat Cancer,Oral Cancer,Nose Cancer
Status: No longer recruiting
Sponsor(s): University of Pennsylvania Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.
Details: OBJECTIVES: I. Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer. II. Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients. PROTOCOL OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32. Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field - Pathologic stage of recurrence must be rT3-4 and/or rN2-3 - The following sites are eligible: Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+; Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+; Any site: Positive margin(s), at least 2 nodes or ECS - No primary tumor of the nasopharynx - Must be eligible for or have undergone complete resection which leaves behind no gross residual disease - Must have prior head and neck irradiation of 45-75 Gy - Lifetime spinal cord radiotherapy dose no greater than 50 Gy - No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery) - No active acute radiation mucositis from previous radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy) - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 6 months since prior radiotherapy; Prior radiotherapy treatment records must be available - Surgery: No prior salvage surgery consisting of partial laryngectomy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 4,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed); Platelet count at least 100,000/mm3 - Hepatic: SGOT or SGPT no greater than 3 times upper limit of normal; Bilirubin no greater than 2 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months; No severe cerebrovascular disease or hypotension not caused by antihypertensive medication - Other: Not pregnant; Fertile patients must use effective contraception; No allergy to cisplatin, fluorouracil, or amifostine; No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MitchellMachtay, Study Chair, University of Pennsylvania Cancer Center
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000066906; UPCC-6398,NCI-V99-1518,ALZA-98-023-ii
Study Start Date: December 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003777
Other Nose Cancer Studies:
1. Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer
2. Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
4. ZD1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck
5. Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Related Studies:
Other Nose Cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
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