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Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
carboplatin
paclitaxel
adjuvant therapy
radiation therapy
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier d'Annecy
  • Institut Sainte Catherine
  • Hopital Duffaut
  • Centre Hospitalier Bayeux
  • Centre Hospitalier de la Cote Basque
  • C.H.G. Beauvais
  • Hopital Avicenne
  • Clinique du Cedre
  • Hopital Saint Andre
  • Clinique Tivoli
  • Polyclinique Bordeaux Nord Aquitaine
  • Polyclinique Du Parc Centre Maurice Tubiana
  • Hopital Louis Pasteur
  • Centre Hospitalier Chateaudun
  • Centre d'Oncologie et de Radiotherapie de Chaumont le Bois
  • Centre Hospitalier Chaumont
  • Hopital Louis Pasteur
  • Clinique des Cedres
  • Centre d'Oncologie et de Radiotherapie du Parc
  • Hopital Jean Monnet
  • Centre Hospitalier D'Evreux
  • Clinique Pasteur
  • Clinique du Petit Colmouilins
  • Centre Mallet - Proux
  • C.H.G Laval
  • Centre Guillaume Le Conquerant
  • Centre Jean Bernard
  • C. H. Du Mans
  • Centre Hospitalier General
  • Hopital Robert Boulin
  • Clinique de le Louviere
  • Clinique Chenieux
  • Centre Hospitalier Robert Bisson
  • Medipole Gentilly Saint-Jacques
  • Hopital Notre-Dame de Bon Secours
  • Clinique du Pont de Chaume
  • C.H. Du Havre
  • Polyclinique Saint - Roch
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Clinique Clementville
  • Centre Hospitalier de Mulhouse
  • Centre D'Oncologie De Gentilly
  • Clinique De Valdegour
  • CHR D'Orleans - Hopital de la Source
  • Hopital Saint-Louis
  • Hopital Tenon
  • C.H.G. De Pau
  • Maison Medicale Marzet
  • Clinique Saint - Pierre
  • Clinique les Bleuets
  • Groupe Medical St. Remy
  • Polyclinique De Courlancy
  • Centre Eugene Marquis
  • Centre Frederic Joliot
  • Clinique Armoricaine De Radiologie
  • Centre Rene Huguenin
  • Centre Hospitalier De Saint Dizier
  • Clinique Saint Vincent
  • Clinique de l'Union
  • Centre Hospitalier de Saint - Brieuc
  • Centre du Rouget
  • C. H. De Saumur
  • Clinique de l'Orangerie
  • Polyclinique de L'Ormeau
  • Centre Hospitalier Regional Metz Thionville
  • Centre Hospitalier de Valenciennes
  • Clinique Medico Chirurgicale Teissier Groupe
  • Centre Hospitalier De Vernon

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Objective response rate
Overall survival
Toxicity

Full Information

First Posted
February 10, 2004
Last Updated
February 6, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00077220
Brief Title
Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
Official Title
Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with or without adjuvant paclitaxel and carboplatin. Secondary Compare the objective response rate in patients treated with these regimens. Compare the overall survival of patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy regimen (conformational vs nonconformational). Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for up to 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 7-7.5 weeks. Three weeks after completion of chemoradiotherapy, patients with stable or responding disease are randomized to 1 of 2 treatment arms. Arm I: Patients undergo routine follow-up. Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a maximum of 3 courses. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 390 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Objective response rate
Title
Overall survival
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean F. Morere, MD
Organizational Affiliation
Hopital Avicenne
Facility Information:
Facility Name
Centre Hospitalier d'Annecy
City
Annecy
ZIP/Postal Code
74011 Cedex
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Hopital Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Centre Hospitalier Bayeux
City
Bayeux
ZIP/Postal Code
14400
Country
France
Facility Name
Centre Hospitalier de la Cote Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
C.H.G. Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Clinique du Cedre
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
F-33000
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Boucher
ZIP/Postal Code
33300
Country
France
Facility Name
Polyclinique Du Parc Centre Maurice Tubiana
City
Caen
ZIP/Postal Code
14052
Country
France
Facility Name
Hopital Louis Pasteur
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Centre Hospitalier Chateaudun
City
Chateaudun
ZIP/Postal Code
28200
Country
France
Facility Name
Centre d'Oncologie et de Radiotherapie de Chaumont le Bois
City
Chaumont
ZIP/Postal Code
52000
Country
France
Facility Name
Centre Hospitalier Chaumont
City
Chaumont
ZIP/Postal Code
52000
Country
France
Facility Name
Hopital Louis Pasteur
City
Comar
ZIP/Postal Code
68021
Country
France
Facility Name
Clinique des Cedres
City
Cornebarrieu
ZIP/Postal Code
31700
Country
France
Facility Name
Centre d'Oncologie et de Radiotherapie du Parc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Jean Monnet
City
Epinal
ZIP/Postal Code
BP590
Country
France
Facility Name
Centre Hospitalier D'Evreux
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Clinique Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Clinique du Petit Colmouilins
City
Harfleur
ZIP/Postal Code
76700
Country
France
Facility Name
Centre Mallet - Proux
City
Laval
ZIP/Postal Code
53000
Country
France
Facility Name
C.H.G Laval
City
Laval
ZIP/Postal Code
53024
Country
France
Facility Name
Centre Guillaume Le Conquerant
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
C. H. Du Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Hospitalier General
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Clinique de le Louviere
City
Lille
ZIP/Postal Code
F-59800
Country
France
Facility Name
Clinique Chenieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier Robert Bisson
City
Lisieux
ZIP/Postal Code
14100
Country
France
Facility Name
Medipole Gentilly Saint-Jacques
City
Maxeville
ZIP/Postal Code
54320
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
55038
Country
France
Facility Name
Clinique du Pont de Chaume
City
Montauban
ZIP/Postal Code
82017
Country
France
Facility Name
C.H. Du Havre
City
Montivilliers
ZIP/Postal Code
F-76290
Country
France
Facility Name
Polyclinique Saint - Roch
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Clinique Clementville
City
Montpellier
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Centre D'Oncologie De Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Clinique De Valdegour
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
C.H.G. De Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Maison Medicale Marzet
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Clinique Saint - Pierre
City
Perpignan
Country
France
Facility Name
Clinique les Bleuets
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Groupe Medical St. Remy
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Frederic Joliot
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Centre Hospitalier De Saint Dizier
City
Saint Dizier
ZIP/Postal Code
52100
Country
France
Facility Name
Clinique Saint Vincent
City
Saint Gregoire
ZIP/Postal Code
35700
Country
France
Facility Name
Clinique de l'Union
City
Saint Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Centre Hospitalier de Saint - Brieuc
City
Saint-Brieuc
ZIP/Postal Code
22023
Country
France
Facility Name
Centre du Rouget
City
Sarcelles
ZIP/Postal Code
95250
Country
France
Facility Name
C. H. De Saumur
City
Saumur
ZIP/Postal Code
49403
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Polyclinique de L'Ormeau
City
Tarbes
ZIP/Postal Code
65000
Country
France
Facility Name
Centre Hospitalier Regional Metz Thionville
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Centre Hospitalier de Valenciennes
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
Clinique Medico Chirurgicale Teissier Groupe
City
Valenciennes
Country
France
Facility Name
Centre Hospitalier De Vernon
City
Vernon
ZIP/Postal Code
27200
Country
France

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer

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