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High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer Clinical research trials and High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer  High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
For Condition: stage 3 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 3 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the hypopharynx,stage 3 squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the larynx
Status: No longer recruiting
Sponsor(s): EORTC Radiotherapy Cooperative 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 if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.
Details: OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative radiotherapy increases the disease-free survival rate of patients with locally advanced head and neck carcinomas at high risk of recurrence following radical surgery. PROTOCOL OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25 days of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear accelerators, or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875. PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed squamous cell carcinoma of the head and neck of the following sites: Oral cavity; Oropharynx; Hypopharynx (only if ineligible for protocol EORTC-24891); Larynx - T3-4, any N, M0 or any T, N2-3, M0 disease (UICC staging) resected with curative intent T3, N0 carcinoma of the larynx with suitable microscopically clear margins is ineligible - At least one of the following high-risk characteristics required: Histopathologically positive surgical margins; No gross residual disease; Perineural involvement; Extranodal spread of disease; Oral cavity or oropharyngeal lesions with metastatic nodes at level 4 or 5; Vascular embolisms in the neck - No metastases at diagnosis - No known CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior locoregional radiotherapy to the head and neck - Surgery: Excision with curative intent required --Patient Characteristics-- - Age: 18 to 70 - Performance status: WHO 0-2 - Hematopoietic: WBC at least 4,000; Platelets at least 100,000; Hemoglobin normal (at least 6.8 mmoles/liter) - Hepatic: Bilirubin no greater than 2 times normal; Other liver function tests no greater than 2 times normal - Renal: Creatinine no greater than 1.3 mg/dL (120 micromoles/liter); Creatinine clearance greater than 60 mL/min - Other: No active, uncontrolled infection; No requirement for antibiotics that might interfere with platinum excretion; No requirement for drugs affecting bone marrow function (e.g., lithium, corticosteroids); No medical condition precluding postoperative chemotherapy; No prior or concurrent malignancy other than nonmelanomatous skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JacquesBernier, Study Chair, EORTC Radiotherapy Cooperative Group
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Ciudad Sanitaria Vall D'Hebron
Barcelona, , 08035
Spain
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Centre Oscar Lambret
Lille, , 59020
France
Hopital Jean Bernard
Poitiers, , 86021
France
Institute of Oncology, Ljubljana
LJUBLJANA, , Sl-1000
Slovenia
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
CHR de Grenoble - La Tronche
Grenoble, , 38043
France
Institut Jules Bordet
Brussels, , 1000
Belgium
Inselspital, Bern
Bern, , CH-3010
Switzerland
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, , 20133
Italy
Medical University of Gdansk
Gdansk, , 80-211
Poland
Dokuz Eylul University School of Medicine
Izmir, , 35340
Turkey
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Universitaetsspital
Zurich, , CH-8091
Switzerland
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Additional Information:
Study ID Numbers: CDR0000063431; EORTC-22931
Study Start Date: February 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002555
Other Stage 3 Squamous Cell Carcinoma Of The Lip And Oral Cavity Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for 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. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
Related Studies:
Other stage 3 squamous cell carcinoma of the lip and oral cavity Clinical Trials
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High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
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