Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 79 Other FRE-GERCOR-B00-1 EU-20330, NCT00077220

Objectives

Primary

1. 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

1. Compare the objective response rate in patients treated with these regimens.
2. Compare the overall survival of patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 to 79

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³

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

Expected Enrollment

A total of 390 patients will be accrued for this study within 3 years.

Outcomes

Progression-free survival

Objective response rate
Overall survival
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Jean Morere, MD, Study coordinator		Ph: 33-1-48-955-032

Registry Information
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
Trial Start Date		2002-06-12
Registered in ClinicalTrials.gov		NCT00077220
Date Submitted to PDQ		2003-12-16
Information Last Verified		2007-05-17

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