Informations générales (source: ClinicalTrials.gov)

NCT00077220 Statut inconnu
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
Interventional
  • Carcinome pulmonaire non à petites cellules
  • Tumeurs du poumon
Phase 3
GERCOR - Multidisciplinary Oncology Cooperative Group (Voir sur ClinicalTrials)
juin 2002
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne Contact (sur clinicalTrials)
AP-HP - Hôpital Tenon Contact (sur clinicalTrials)
CDS MEDICO-DENTAIRE MONTREUIL ROUGET Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
C.H.G. Beauvais - 60021 - Beauvais - France Contact (sur clinicalTrials)
C.H.G. De Pau - 64000 - Pau - France Contact (sur clinicalTrials)
Centre D'Oncologie De Gentilly - 54100 - Nancy - France Contact (sur clinicalTrials)
Centre d'Oncologie et de Radiotherapie du Parc - 21000 - Dijon - France Contact (sur clinicalTrials)
Centre Eugene Marquis - 35042 - Rennes - France Contact (sur clinicalTrials)
Centre Frederic Joliot - 76000 - Rouen - France Contact (sur clinicalTrials)
Centre Guillaume Le Conquerant - 76600 - Le Havre - France Contact (sur clinicalTrials)
Centre Hospitalier Bayeux - 14400 - Bayeux - France Contact (sur clinicalTrials)
Centre Hospitalier Chaumont - 52000 - Chaumont - France Contact (sur clinicalTrials)
Centre Hospitalier d'Annecy - 74011 Cedex - Annecy - France Contact (sur clinicalTrials)
Centre Hospitalier de la Cote Basque - 64100 - Bayonne - France Contact (sur clinicalTrials)
Centre Hospitalier de Mulhouse - 68051 - Mulhouse - France Contact (sur clinicalTrials)
Centre Hospitalier de Saint - Brieuc - 22023 - Saint-Brieuc - France Contact (sur clinicalTrials)
Centre Hospitalier De Saint Dizier - 52100 - Saint Dizier - France Contact (sur clinicalTrials)
Centre Hospitalier Regional Metz Thionville - 57126 - Thionville - France Contact (sur clinicalTrials)
Centre Hospitalier Robert Bisson - 14100 - Lisieux - France Contact (sur clinicalTrials)
Centre Jean Bernard - 72000 - Le Mans - France Contact (sur clinicalTrials)
Centre Mallet - Proux - 53000 - Laval - France Contact (sur clinicalTrials)
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle - 34298 - Montpellier - France Contact (sur clinicalTrials)
CHR D'Orleans - Hopital de la Source - 45100 - Orleans - France Contact (sur clinicalTrials)
Clinique Chenieux - 87000 - Limoges - France Contact (sur clinicalTrials)
Clinique de l'Orangerie - 67010 - Strasbourg - France Contact (sur clinicalTrials)
Clinique des Cedres - 31700 - Cornebarrieu - France Contact (sur clinicalTrials)
Clinique du Cedre - 76230 - Bois-Guillaume - France Contact (sur clinicalTrials)
Clinique du Petit Colmouilins - 76700 - Harfleur - France Contact (sur clinicalTrials)
Clinique Pasteur - 27000 - Evreux - France Contact (sur clinicalTrials)
Clinique Saint - Pierre - Perpignan - France Contact (sur clinicalTrials)
Clinique Saint Vincent - 35700 - Saint Gregoire - France Contact (sur clinicalTrials)
Hopital Jean Monnet - BP590 - Epinal - France Contact (sur clinicalTrials)
Hopital Louis Pasteur - 28018 - Chartres - France Contact (sur clinicalTrials)
Hopital Louis Pasteur - 68021 - Comar - France Contact (sur clinicalTrials)
Hopital Notre-Dame de Bon Secours - 55038 - Metz - France Contact (sur clinicalTrials)
Hopital Robert Boulin - 33500 - Libourne - France Contact (sur clinicalTrials)
Hopital Saint Andre - 33075 - Bordeaux - France Contact (sur clinicalTrials)
Hopital Saint-Louis - 75475 - Paris - France Contact (sur clinicalTrials)
Institut Sainte Catherine - 84082 - Avignon - France Contact (sur clinicalTrials)
Maison Medicale Marzet - 64000 - Pau - France Contact (sur clinicalTrials)
Polyclinique Bordeaux Nord Aquitaine - 33300 - Boucher - France Contact (sur clinicalTrials)
Polyclinique De Courlancy - F-51100 - Reims - France Contact (sur clinicalTrials)
Polyclinique Du Parc Centre Maurice Tubiana - 14052 - Caen - France Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
C. H. De Saumur - 49403 - Saumur - France Contact (sur clinicalTrials)
C. H. Du Mans - 72037 - Le Mans - France Contact (sur clinicalTrials)
C.H. Du Havre - F-76290 - Montivilliers - France Contact (sur clinicalTrials)
C.H.G Laval - 53024 - Laval - France Contact (sur clinicalTrials)
Centre d'Oncologie et de Radiotherapie de Chaumont le Bois - 52000 - Chaumont - France Contact (sur clinicalTrials)
Centre Hospitalier Chateaudun - 28200 - Chateaudun - France Contact (sur clinicalTrials)
Centre Hospitalier de Valenciennes - 59300 - Valenciennes - France Contact (sur clinicalTrials)
Centre Hospitalier De Vernon - 27200 - Vernon - France Contact (sur clinicalTrials)
Centre Hospitalier D'Evreux - 27000 - Evreux - France Contact (sur clinicalTrials)
Centre Hospitalier General - 72037 - Le Mans - France Contact (sur clinicalTrials)
Centre Rene Huguenin - 92211 - Saint Cloud - France Contact (sur clinicalTrials)
Clinique Armoricaine De Radiologie - F-22015 - Saint Brieuc - France Contact (sur clinicalTrials)
Clinique Clementville - Montpellier - France Contact (sur clinicalTrials)
Clinique de le Louviere - F-59800 - Lille - France Contact (sur clinicalTrials)
Clinique de l'Union - 31240 - Saint Jean - France Contact (sur clinicalTrials)
Clinique De Valdegour - 30900 - Nimes - France Contact (sur clinicalTrials)
Clinique du Pont de Chaume - 82017 - Montauban - France Contact (sur clinicalTrials)
Clinique les Bleuets - 51100 - Reims - France Contact (sur clinicalTrials)
Clinique Medico Chirurgicale Teissier Groupe - Valenciennes - France Contact (sur clinicalTrials)
Clinique Tivoli - F-33000 - Bordeaux - France Contact (sur clinicalTrials)
Groupe Medical St. Remy - 51100 - Reims - France Contact (sur clinicalTrials)
Hopital Duffaut - 84902 - Avignon - France Contact (sur clinicalTrials)
Medipole Gentilly Saint-Jacques - 54320 - Maxeville - France Contact (sur clinicalTrials)
Polyclinique de L'Ormeau - 65000 - Tarbes - France Contact (sur clinicalTrials)
Polyclinique Saint - Roch - 34000 - Montpellier - France Contact (sur clinicalTrials)

Critères

Tous
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