NCT00011921

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell transplant or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell or bone marrow transplant is more effective than chemotherapy alone in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P50-P75 for phase_3 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

March 1, 2003

First QC Date

March 3, 2001

Last Update Submit

September 16, 2013

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancerextensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS) at 3 years

Secondary Outcomes (3)

  • Progression-free survival (PFS) at 3 years

  • Toxicity at 3 years

  • Quality of life (QOL) at 3 years

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
epirubicin hydrochlorideDRUG
etoposideDRUG
etoposide phosphateDRUG
ifosfamideDRUG
paclitaxelDRUG
autologous bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer * Limited disease or extensive disease with no more than 2 metastatic sites * No CNS metastasis PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 OR * Platelet count greater than 100,000/mm\^3 OR * Hemoglobin at least 10.0 g/dL Hepatic: * AST/ALT less than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 2.5 times ULN * Bilirubin less than 2.5 times ULN Renal: * Creatinine clearance at least 60 mL/min * No renal function that would preclude chemotherapy Cardiovascular: * No congestive heart failure * LVEF at least 50% * No cardiac function that would preclude chemotherapy Other: * No other malignancy within the past 3 years except for basal cell skin cancer or carcinoma in situ of the cervix * No psychiatric disorder or any other disorder that would preclude study participation * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

FilgrastimCarboplatinEpirubicinEtoposideetoposide phosphateIfosfamidePaclitaxelPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Serge Leyvraz, MD

    Centre Hospitalier Universitaire Vaudois

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 3, 2001

First Posted

January 27, 2003

Study Start

September 1, 1997

Last Updated

September 17, 2013

Record last verified: 2003-03

Locations

CH(1)