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

NCT00002858 | Unknown Phase 3

• 3 other identifiers: CDR0000065122FRE-CPC014EU-96009
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 19

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.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Interventions

cisplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (19)

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

Centre Paul Papin

Angers, 49036, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

Centre Hospitalier Sud Francilien - Site Corbeil

Corbeil, 91100, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Hopital De La Trouhade

Dijon, 21034, France

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

C.H. General Andre Boulloche

Montbéliard, 25209, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

C.H. De Saumur

Saumur, 49403, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Therapeutics

Study Officials

• Thierry L. Le Chevalier, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 12, 2004
• Study Start: March 1, 1993
• Last Updated: February 9, 2009

Record last verified: 2007-05

Locations

FR (19)