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Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx Clinical research trials and Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx. Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx clinical trial. Participants oftentimes recieve the finest healthcare available for their Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx  Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
For Condition: stage 4 squamous cell carcinoma of the hypopharynx,stage 3 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the oropharynx
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
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. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.
Details: OBJECTIVES: I. Compare the overall survival and survival without relapse for 1, 3, and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil. II. Compare the presence of distant metastases at 1, 3, and 5 years in these patients after these treatments. III. Compare the local control and duration of control in these patients after these treatments. IV. Compare the clinical changes and histological changes at 6 months in these patients after these treatments. V. Determine the rate of complete response in these patients after these treatments. VI. Determine the early and late toxic effects of these regimens in these patients. VII. Determine the quality of life of these patients. VIII. Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and primary site of disease (oropharynx vs hypopharynx) Patients are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7 weeks. Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5. Courses are repeated every 3 weeks for 3 courses. Patients are followed every month for 1 year, every 2-3 months for 2 years, then every 6 months for at least 2 years. PROJECTED ACCRUAL: A total of 160 patients (80/arm) will be accrued for this study within 4.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven squamous cell cancer of the oropharynx or hypopharynx - T4 and nonresectable OR - T3 extended to oropharynx or hypopharynx and nonresectable - N0-3 (stage III or IV) No distant metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: - No prior chemotherapy - No concurrent antineoplastic therapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior surgery (except biopsy or adenectomy) --Patient Characteristics-- Age: 18 to 70 Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: - Neutrophil count at least 2000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - Transaminases no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No severe cardiac disease Other: - No prior malignancy except basal cell skin cancer - No uncontrolled infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Rene-JeanBensadoun, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Centre Oscar Lambret
Lille, , 59020
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Centre Henri Becquerel
Rouen, , 76038
France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
CHU de la Timone
Marseille, , 13385
France
Institut Jean Godinot
Reims, , 51056
France
Centre Antoine Lacassagne
Nice, , 06189
France
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Centre Rene Huguenin
Saint Cloud, , 92211
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Additional Information:
Study ID Numbers: CDR0000066710; FRE-FNCLCC-96003,EU-98027
Study Start Date: October 1998
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003627
Other Stage 4 Squamous Cell Carcinoma Of The Hypopharynx Studies:
1. Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Head and Neck Cancer
2. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
3. Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
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 4 squamous cell carcinoma of the hypopharynx Clinical Trials
Other Clinical Trials
Other Lille Clinical Trials
Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
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