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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
For Condition: limited stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): Institut Gustave Roussy ,
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 chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.
Details: OBJECTIVES: I. Compare the effect on 2-year disease-free survival of two different doses of cyclophosphamide as part of first induction chemotherapy followed by alternating chemotherapy and chest irradiation in patients with limited stage small cell lung cancer. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. All patients receive 2 courses of induction chemotherapy with doxorubicin, etoposide, cisplatin, and cyclophosphamide. For the first course, one group of patients receives a lower dose of cyclophosphamide than the other group. Both groups receive the same, and still lower, dose of cyclophosphamide during the second course. Beginning 1 week after the completion of induction therapy, patients receive 3 alternating courses each of radiotherapy to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as in the second course of induction. Each course is initiated after a 1-week rest. Patients receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy course. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 280 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven small cell lung cancer with no distant metastases - Size of initial lesion suitable for total irradiation; Positive subclavicular nodes allowed; No malignant pleural effusion; No extension into contralateral lung --Prior/Concurrent Therapy-- - No prior chemotherapy, radiotherapy, or surgery --Patient Characteristics-- - Age: Under 70 - Performance status: Karnofsky 60%-100% - Hematopoietic: WBC greater than 2,000; Platelets greater than 125,000 - Hepatic: Not specified - Renal: Creatinine less than 1.1 mg/dL (100 micromoles/L) - Cardiovascular: No myocardial infarction within 6 months; No other cardiovascular disease that precludes protocol treatment - Other: No hearing loss; No prior or concurrent malignancy except: Basal cell skin carcinoma; In situ carcinoma of the cervix; Accessible for follow-up
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThierryChevalier, Study Chair, Institut Gustave Roussy
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Hopitaux Universitaire de Strasbourg
Strasbourg, , 67091
France
Centre Paul Papin
Angers, , 49036
France
Centre Antoine Lacassagne
Nice, , 06189
France
C.H. De Saumur
Saumur, , 49403
France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
CHRU de Nancy - Hopitaux de Brabois
Vandoeuvre-les-Nancy, , 54511
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Hopital Intercommunal De Creteil
Creteil, , 94010
France
Centre Hospitalier Sud Francilien - Site Corbeil
Corbeil, , 91100
France
Centre Regional Francois Baclesse
Caen, , 14076
France
Institut Bergonie
Bordeaux, , 33076
France
Institut Claudius Regaud
Toulouse, , 31052
France
Hopital De La Trouhade
Dijon, , 21034
France
C.H. General Andre Boulloche
Montbeliard, , 25209
France
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , 49033
France
Hopital Haut Leveque
Pessac, , 33604
France
Hopital Antoine Beclere
Clamart, , 92141
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Additional Information:
Study ID Numbers: CDR0000065122; FRE-CPC014,EU-96009
Study Start Date: March 1993
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002858
Other Limited Stage Small Cell Lung Cancer Studies:
1. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
2. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
3. Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
4. Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
5. ZD6474 in Treating Patients With Small Cell Lung Cancer
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other Clinical Trials
Other Angers Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
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