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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Institut Gustave Roussy
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002858
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Procedure: radiation therapy
Phase III

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Etoposide    Cisplatin    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   280
Study Start Date:   March 1993

Detailed Description:

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.

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
Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or surgery

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002858

Locations
France
C.H. De Saumur    
      Saumur, France, 49403
C.H. General Andre Boulloche    
      Montbeliard, France, 25209
Centre Alexis Vautrin    
      Vandoeuvre-les-Nancy, France, 54511
Centre Antoine Lacassagne    
      Nice, France, 06189
Centre de Lute Contre le Cancer,Georges-Francois Leclerc    
      Dijon, France, 21079
Centre Hospitalier Regional et Universitaire d'Angers    
      Angers, France, 49033
Centre Hospitalier Sud Francilien - Site Corbeil    
      Corbeil, France, 91100
Centre Paul Papin    
      Angers, France, 49036
Centre Regional Francois Baclesse    
      Caen, France, 14076
Institut Gustave Roussy    
      Villejuif, France, F-94805
CRLCC Nantes - Atlantique    
      Nantes-Saint Herblain, France, 44805
Hopital Antoine Beclere    
      Clamart, France, 92141
Hopital De La Trouhade    
      Dijon, France, 21034
Hopital Haut Leveque    
      Pessac, France, 33604
Hopital Intercommunal De Creteil    
      Creteil, France, 94010
Hopitaux Universitaire de Strasbourg    
      Strasbourg, France, 67091
Institut Bergonie    
      Bordeaux, France, 33076
Institut Claudius Regaud    
      Toulouse, France, 31052
CHRU de Nancy - Hopitaux de Brabois    
      Vandoeuvre-Les-Nancy, France, 54511

Sponsors and Collaborators
Institut Gustave Roussy

Investigators
Study Chair:     Thierry L. Le Chevalier, MD     Institut Gustave Roussy    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065122, FRE-CPC014, EU-96009
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002858
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Cyclophosphamide
Etoposide phosphate
Doxorubicin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 10, 2008




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