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

PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: cyclophosphamide; Radiation: radiation therapy; Drug: etoposide; Drug: cisplatin; Drug: doxorubicin hydrochloride

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
• Enrollment (Anticipated): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 69 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Study Chair: Thierry L. Le Chevalier, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start: March 1, 1993

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: March 11, 2004
• First Posted (Estimate): March 12, 2004

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: limited stage small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Etoposide; Cisplatin; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CDR0000065122; FRE-CPC014; EU-96009