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Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery Clinical research trials and Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery clinical trial. Human subjects often get the best healthcare possible for their Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery  Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
For Condition: Laryngeal Cancer,Hypopharyngeal Cancer,lip and oral cavity cancer,paranasal sinus and nasal cavity cancer,Oropharyngeal Cancer
Status: Recruiting
Sponsor(s): NMRC Head and Neck Cancer Group ,
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. It is not yet known whether surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery plus radiation therapy to chemotherapy plus radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery.
Details: OBJECTIVES: - Compare the complete response rate, disease-free survival, and overall survival of patients with resectable (nonmetastatic) stage III or IV squamous cell cancer of the head and neck treated with surgery and adjuvant radiotherapy versus concurrent chemo-radiotherapy. OUTLINE: This is a randomized study. Patients are stratified according to primary site of disease (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node negative vs positive). - Arm I: Patients undergo resection of the tumor, followed no more than 6 weeks later by radiotherapy to the primary tumor and upper neck once a day, 5 days a week, for 6 weeks. - Arm II: Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and cisplatin. Radiotherapy is given once a day, 5 days a week, for 6.5 weeks to the primary tumor and upper neck. Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy. A second course of fluorouracil and cisplatin is given on day 28. Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery. Patients are followed once a month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months thereafter. PROJECTED ACCRUAL: Approximately 200 patients will be accrued over a 4-5 year period.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed head and neck squamous cell cancer (excluding nasopharynx and salivary glands) on biopsy of the primary lesion or the neck mass - Stage III or IV disease - No evidence of distant or systemic metastases - Resectable disease PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - SGOT less than 2 times upper limit of normal - Bilirubin less than 1.4 mg/dL Renal: - Creatinine less than 1.6 mg/dL Other: - No prior or concurrent primary malignancies - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the head and neck Surgery: - See Disease Characteristics - No prior surgery (other than biopsy)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SooChee, Study Chair, National Cancer Centre - Singapore
National Cancer Centre - Singapore *Recruiting*
Singapore, , 169610
Singapore
Recruiting Soo Chee 65-4368205
Additional Information:
Study ID Numbers: CDR0000066643; NMRC-SHN01,EU-97015
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003576
Other Paranasal Sinus And Nasal Cavity Cancer Studies:
1. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
2. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
3. Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
4. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
5. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
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Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
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