NCT00077220

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

68 active sites

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
Last Updated

February 9, 2009

Status Verified

May 1, 2007

First QC Date

February 10, 2004

Last Update Submit

February 6, 2009

Conditions

Keywords

stage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (3)

  • Objective response rate

  • Overall survival

  • Toxicity

Interventions

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage II or III disease * Not amenable to surgery * Measurable or evaluable disease * No T4 apical localization * Lesions able to be covered in a 60 Gy minimum volume of radiation * No pleural effusion PATIENT CHARACTERISTICS: Age * 18 to 79 Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) Renal * Creatinine \< 1.25 times ULN Cardiovascular * No unstable heart disease Pulmonary * No ventilation dysfunction that would preclude radiotherapy Other * No weight loss of 15% or more within the past 2 months * No uncontrolled infection * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior neoadjuvant chemotherapy * No prior adjuvant chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy Surgery * Not specified Other * No other concurrent clinical trial participation

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

Sponsors & Collaborators

Study Sites (68)

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Centre Hospitalier Bayeux

Bayeux, 14400, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Clinique du Cedre

Bois-Guillaume, 76230, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

Polyclinique Du Parc Centre Maurice Tubiana

Caen, 14052, France

Location

Hopital Louis Pasteur

Chartres, 28018, France

Location

Centre d'Oncologie et de Radiotherapie de Chaumont le Bois

Chaumont, 52000, France

Location

Centre Hospitalier Chaumont

Chaumont, 52000, France

Location

Centre Hospitalier Chateaudun

Châteaudun, 28200, France

Location

Hopital Louis Pasteur

Comar, 68021, France

Location

Clinique des Cedres

Cornebarrieu, 31700, France

Location

Centre d'Oncologie et de Radiotherapie du Parc

Dijon, 21000, France

Location

Hopital Jean Monnet

Épinal, BP590, France

Location

Centre Hospitalier D'Evreux

Évreux, 27000, France

Location

Clinique Pasteur

Évreux, 27000, France

Location

Clinique du Petit Colmouilins

Harfleur, 76700, France

Location

Centre Mallet - Proux

Laval, 53000, France

Location

C.H.G Laval

Laval, 53024, France

Location

Centre Guillaume Le Conquerant

Le Havre, 76600, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

C. H. Du Mans

Le Mans, 72037, France

Location

Centre Hospitalier General

Le Mans, 72037, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Clinique de le Louviere

Lille, F-59800, France

Location

Clinique Chenieux

Limoges, 87000, France

Location

Centre Hospitalier Robert Bisson

Lisieux, 14100, France

Location

Medipole Gentilly Saint-Jacques

Maxéville, 54320, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 55038, France

Location

Clinique du Pont de Chaume

Montauban, 82017, France

Location

C.H. Du Havre

Montivilliers, F-76290, France

Location

Polyclinique Saint - Roch

Montpellier, 34000, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Clinique Clementville

Montpellier, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre D'Oncologie De Gentilly

Nancy, 54100, France

Location

Clinique De Valdegour

Nîmes, 30900, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45100, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Tenon

Paris, 75970, France

Location

C.H.G. De Pau

Pau, 64000, France

Location

Maison Medicale Marzet

Pau, 64000, France

Location

Clinique Saint - Pierre

Perpignan, France

Location

Clinique les Bleuets

Reims, 51100, France

Location

Groupe Medical St. Remy

Reims, 51100, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Frederic Joliot

Rouen, 76000, France

Location

Centre Hospitalier de Saint - Brieuc

Saint-Brieuc, 22023, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Centre Hospitalier De Saint Dizier

Saint-Dizier, 52100, France

Location

Clinique Saint Vincent

Saint-Grégoire, 35700, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

C. H. De Saumur

Saumur, 49403, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Polyclinique de L'Ormeau

Tarbes, 65000, France

Location

Centre Hospitalier Regional Metz Thionville

Thionville, 57126, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

Clinique Medico Chirurgicale Teissier Groupe

Valenciennes, France

Location

Centre Hospitalier De Vernon

Vernon, 27200, France

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxelChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jean F. Morere, MD

    Hopital Avicenne

Study Design

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

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 11, 2004

Study Start

June 1, 2002

Last Updated

February 9, 2009

Record last verified: 2007-05

Locations