Clinical trial NCT00077220: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-02-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

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