|
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer 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 Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer 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 Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer 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 Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer clinical trial. Human subjects often get the best healthcare possible for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer 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.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
For Condition: stage 3 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the hypopharynx,stage 3 squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the lip and oral cavity
Status: No longer recruiting
Sponsor(s): EORTC Head and Neck Cancer Cooperative Group ,
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. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer.
Details: OBJECTIVES: I. Compare the progression free survival of patients with locally advanced, inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy. II. Compare the response rate, response duration, toxicity, local symptoms, and time to disease progression of these treatment regimens in this patient population. III. Evaluate the quality of life in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and institution. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV over 1 hour, immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil (5-FU) IV as a continuous infusion on days 1-5. Arm II: Patients receive cisplatin IV over 1 hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course. Radiotherapy is administered 5 days a week for up to 7 weeks. Quality of life is assessed before treatment, at courses 2 and 4, and at 6 and 9 months. Patients are followed every 3 months for the first 2 years and then every 6 months until death. PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven locally advanced squamous cell carcinoma of the head and neck; Stage III or IV without distant metastases; Unresectable - Primary tumor sites: Oral cavity; Oropharynx; Hypopharynx; Larynx - Must have at least one measurable lesion --Prior/Concurrent Therapy-- - Biologic therapy: No primary prophylactic colony stimulating factors during the first course of therapy - Chemotherapy: No prior or concurrent chemotherapy - Endocrine therapy: At least 3 weeks since prior corticosteroid; No chronic corticosteroid therapy (greater than 3 months) - Radiotherapy: No prior radiotherapy - Surgery: No prior surgery for this cancer - Other: At least 30 days since prior treatment in a clinical trial; No concurrent use of drugs that interact with fluorouracil (e.g., cimetidine, allopurinol, folic acid or leucovorin calcium); No other concurrent investigational drugs or anticancer treatment --Patient Characteristics-- - Age: 18 to 70 - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than upper limit of normal (ULN); SGOT and SGPT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 5 times ULN; No SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN - Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: At least 6 months since prior myocardial infarction; No unstable, treated cardiac disease - Pulmonary: At least one year since prior hospitalization for chronic obstructive pulmonary disease - Neurologic: No neurologic or psychiatric disorders (e.g., dementia or seizures); No concurrent peripheral neuropathy greater than grade 1 - Other: No active uncontrolled infection; No active peptic ulcer; No alteration in hearing; At least 5 years since any other neoplastic disease except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated by surgery; Not pregnant or nursing; Fertile patients must use effective contraception; No other psychological, familial, sociological, or geographical condition that would prevent compliance
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JanVermorken, Study Chair, EORTC Head and Neck Cancer Cooperative Group
Centre Antoine Lacassagne
Nice, , 06189
France
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Ospedale Santa Croce
Cuneo, , 12100
Italy
Caritasklinik St. Theresia
Saarbrucken, , D-66113
Germany
Centro di Riferimento Oncologico - Aviano
Aviano, , 33081
Italy
Martin Luther Universitaet
Halle, , DOH-0-6112
Germany
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
Centre Leon Berard
Lyon, , 69373
France
Centre Oscar Lambret
Lille, , 59020
France
Borsod-Abauj-Zemplen County Hospital
Miskolc, , 3501
Hungary
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , 5530
Belgium
Hospital Clinico Universitario de Valencia
Valencia, , 46010
Spain
Charing Cross Hospital
London, England, W6 8RF
United Kingdom
Academisch Ziekenhuis Maastricht
Maastricht, , 6202 AZ
Netherlands
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Ospedale di Circolo e Fondazione Macchi
Varese, , 21100
Italy
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Szent Margit Hospital
Budapest, , 3761
Hungary
Istanbul University-Institute of Oncology
Istanbul, , 34390
Turkey
Landeskrankenhaus/Universitatskliniken Graz
Graz, , A-8036
Austria
CHR de Besancon - Hopital Jean Minjoz
Besancon, , 25030
France
Hospital General de Jerez
Jerez, , 11407
Spain
National Cancer Institute - Bratislava
Bratislava, , 833 10
Slovakia
Institut Jules Bordet
Brussels, , 1000
Belgium
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Kantonspital Aarau
AARAU, , 5001
Switzerland
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Universidad de Santiago - Hospital de Conxo
Santiago de Compostela, ,
Spain
Mutterhaus der Borromaerinnen
Trier, , D-54219
Germany
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , 08907
Spain
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Centre Hospital Regional Universitaire de Limoges
Limoges, , 87042
France
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Ahepa University Hospital
THESSALONIKI, , 54636
Greece
Centre Hospitalier Regional de la Citadelle
LIEGE, , 4000
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Allgemeines Krankenhaus der Stadt Wien
Vienna, , A-1090
Austria
CHR Hotel Dieu
Nantes, , 44093
France
Institute of Oncology and Radiology of Serbia
Belgrade, , 11000
Yugoslavia
National Institute of Oncology
Budapest, , 1125
Hungary
Additional Information:
Study ID Numbers: CDR0000067057; EORTC-24971,RP-56976-V-323
Study Start Date: April 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003888
Other Stage 3 Squamous Cell Carcinoma Of The Oropharynx Studies:
1. Chemotherapy With or Without Docetaxel Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
2. Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
3. Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
4. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
5. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Related Studies:
Other stage 3 squamous cell carcinoma of the oropharynx Clinical Trials
Other Clinical Trials
Other Rome Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
|
|
|
|
|
|
|
|
