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Radiation Therapy With or Without Epoetin alfa in Treating Patients With 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 Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer Clinical research trials and Radiation Therapy With or Without Epoetin alfa in Treating Patients With 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 Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer. Radiation Therapy With or Without Epoetin alfa in Treating Patients With 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 Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer clinical trial. Subjects frequently get the best healthcare possible for their Radiation Therapy With or Without Epoetin alfa in Treating Patients With 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 > "R" Clinical Trials Conditions > Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer  Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer
Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer
For Condition: Throat Cancer,Oral Cancer
Status: No longer recruiting
Sponsor(s): EORTC Radiotherapy Cooperative Group , EORTC Head and Neck Cancer Cooperative Group,Trans-Tasman Radiation Oncological Group,Arbeitsgemeinschaft Radiologische Onkologie,Groupe d'Oncologie et Radiotherapie Tete et Cou,Radius Hungaricus Oncology Group,Grup per l'Estudi dels Limfomes de Catalunya i Balears
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.
Details: OBJECTIVES: - Compare the efficacy of radiotherapy (in terms of local-regional control) with or without epoetin alfa in patients with squamous cell carcinoma of the head and neck. - Compare the disease-specific and overall survival of patients treated with these regimens. - Compare the hemoglobin level of these patients during radiotherapy. - Compare the acute and late toxic effects of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, site of disease (larynx vs hypopharynx vs oropharynx vs oral cavity), T-classification (T1-2 vs T3-4), N-classification and intent of systematic neck node dissection (N0-1 vs N2-3 without node dissection vs N2-3 with node dissection), hemoglobin level and gender (men with 10-12.5 g/dL vs men with 12.5-14 g/dL vs women with 10-12 g/dL vs women with 12-13.5 g/dL), and type of treatment (EORTC standard vs other vs randomized in other trials). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo standard radiotherapy 5 days a week and receive concurrent epoetin alfa subcutaneously (SC) once weekly. - Arm II: Patients undergo radiotherapy as in arm I and receive concurrent placebo SC once weekly. Treatment on both arms continues for 6-8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 3-6 weeks and 9-14 weeks, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter. After any locoregional recurrence, patients are followed every 6 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity, larynx, oropharynx, or hypopharynx - Stage T1-T4, any N - No T1, N0 glottic tumor - No nodal disease from unknown primary - Previously untreated disease - No distant metastases - Planned radiotherapy PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Hemoglobin greater than 10 g/dL but no greater than 14 g/dL for men - Hemoglobin greater than 10 g/dL but no greater than 13.5 g/dL for women Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No hypertension (diastolic pressure greater than 100 mmHg) refractory to treatment - No symptomatic cardiovascular disease - No deep vein thrombosis Other: - No other malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix - No psychological, familial, sociological, or geographical condition that would preclude study compliance - No smoking during study - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior neoadjuvant chemotherapy - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to head and neck area - No concurrent nonconventional radiotherapy Surgery: - No prior therapeutic surgery to head and neck area
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VolkerBudach, Study Chair, Universitaetsklinikum Charite
Rambam Medical Center
Haifa, , 31096
Israel
Radius Hungaricus Oncology Group
Torokbalint, , H-2045
Hungary
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, NSW 2310
Australia
Institut Jules Bordet
Brussels (Bruxelles), , 1000
Belgium
Hospital de la Santa Cruz I Sant Pau
Barcelona, , 08025
Spain
Radiotherapeutisch Instituut Limburg
HEERLEN, , NL-6401 PC
Netherlands
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), , 1200
Belgium
Hopital de Jolimont
Haine-Saint-Paul, , 7100
Belgium
Universitaetsklinikum Charite
Berlin, , D-10117
Germany
Institut Gustave Roussy
Villejuif, , F-94805
France
Clinique Sainte Elisabeth
Namur, , 5000
Belgium
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Additional Information:
Study ID Numbers: CDR0000068669; ARO-EORTC-22996,GORTEC-EORTC-22996,GELCB-EORTC-22996,EORTC-22996,EORTC-HN-22996,RHOG-EORTC-22996,TROG-EORTC-22996
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017277
Other Oral Cancer Studies:
1. Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
2. ZD1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
4. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
5. Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Related Studies:
Other Oral Cancer Clinical Trials
Other Clinical Trials
Other HEERLEN Clinical Trials
Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer
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