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

February 6, 2009 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital 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 - Hopitaux de Brabois
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065122
  • FRE-CPC014
  • EU-96009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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