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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002858
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2004
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Radiation: radiation therapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : March 1993

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002858

Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
Centre Paul Papin
Angers, France, 49036
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Hopital Antoine Beclere
Clamart, France, 92141
Centre Hospitalier Sud Francilien - Site Corbeil
Corbeil, France, 91100
Hopital Intercommunal De Creteil
Creteil, France, 94010
Hopital De La Trouhade
Dijon, France, 21034
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
C.H. General Andre Boulloche
Montbeliard, France, 25209
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Haut Leveque
Pessac, France, 33604
C.H. De Saumur
Saumur, France, 49403
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
CHRU de Nancy - Hopitaux de Brabois
Vandoeuvre-Les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Thierry L. Le Chevalier, MD Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00002858     History of Changes
Other Study ID Numbers: CDR0000065122
First Posted: March 12, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: May 2007

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

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic