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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00077220
• Other study ID #: CDR0000350015
• Secondary ID: FRE-GERCOR-B00-1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 10, 2004
• Last updated: February 6, 2009
• Start date: June 2002

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• paclitaxel

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Hospitalier d'Annecy	Annecy
France	Hopital Duffaut	Avignon
France	Institut Sainte Catherine	Avignon
France	Centre Hospitalier Bayeux	Bayeux
France	Centre Hospitalier de la Cote Basque	Bayonne
France	C.H.G. Beauvais	Beauvais
France	Hopital Avicenne	Bobigny
France	Clinique du Cedre	Bois-Guillaume
France	Clinique Tivoli	Bordeaux
France	Hopital Saint Andre	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Boucher
France	Polyclinique Du Parc Centre Maurice Tubiana	Caen
France	Hopital Louis Pasteur	Chartres
France	Centre Hospitalier Chateaudun	Chateaudun
France	Centre d'Oncologie et de Radiotherapie de Chaumont le Bois	Chaumont
France	Centre Hospitalier Chaumont	Chaumont
France	Hopital Louis Pasteur	Comar
France	Clinique des Cedres	Cornebarrieu
France	Centre d'Oncologie et de Radiotherapie du Parc	Dijon
France	Hopital Jean Monnet	Epinal
France	Centre Hospitalier D'Evreux	Evreux
France	Clinique Pasteur	Evreux
France	Clinique du Petit Colmouilins	Harfleur
France	C.H.G Laval	Laval
France	Centre Mallet - Proux	Laval
France	Centre Guillaume Le Conquerant	Le Havre
France	C. H. Du Mans	Le Mans
France	Centre Hospitalier General	Le Mans
France	Centre Jean Bernard	Le Mans
France	Hopital Robert Boulin	Libourne
France	Clinique de le Louviere	Lille
France	Clinique Chenieux	Limoges
France	Centre Hospitalier Robert Bisson	Lisieux
France	Medipole Gentilly Saint-Jacques	Maxeville
France	Hopital Notre-Dame de Bon Secours	Metz
France	Clinique du Pont de Chaume	Montauban
France	C.H. Du Havre	Montivilliers
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Clinique Clementville	Montpellier
France	Polyclinique Saint - Roch	Montpellier
France	Centre Hospitalier de Mulhouse	Mulhouse
France	Centre D'Oncologie De Gentilly	Nancy
France	Clinique De Valdegour	Nimes
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	C.H.G. De Pau	Pau
France	Maison Medicale Marzet	Pau
France	Clinique Saint - Pierre	Perpignan
France	Clinique les Bleuets	Reims
France	Groupe Medical St. Remy	Reims
France	Polyclinique De Courlancy	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Frederic Joliot	Rouen
France	Clinique Armoricaine De Radiologie	Saint Brieuc
France	Centre Rene Huguenin	Saint Cloud
France	Centre Hospitalier De Saint Dizier	Saint Dizier
France	Clinique Saint Vincent	Saint Gregoire
France	Clinique de l'Union	Saint Jean
France	Centre Hospitalier de Saint - Brieuc	Saint-Brieuc
France	Centre du Rouget	Sarcelles
France	C. H. De Saumur	Saumur
France	Clinique de l'Orangerie	Strasbourg
France	Polyclinique de L'Ormeau	Tarbes
France	Centre Hospitalier Regional Metz Thionville	Thionville
France	Centre Hospitalier de Valenciennes	Valenciennes
France	Clinique Medico Chirurgicale Teissier Groupe	Valenciennes
France	Centre Hospitalier De Vernon	Vernon

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Objective response rate			No
Secondary	Overall survival			No
Secondary	Toxicity			Yes