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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 3

Conditions

Lung Cancer

Treatments

Drug: paclitaxel

Radiation: radiation therapy

Drug: carboplatin

Procedure: adjuvant therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00077220

EU-20330

FRE-GERCOR-B00-1

CDR0000350015

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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