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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

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ClinicalTrials.gov Identifier: NCT00077220
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2004
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
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 Start Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Objective response rate
  2. Overall survival
  3. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 79

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • Bilirubin < 1.5 times upper limit of normal (ULN)


  • Creatinine < 1.25 times ULN


  • No unstable heart disease


  • No ventilation dysfunction that would preclude radiotherapy


  • 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


Biologic therapy

  • Not specified


  • More than 6 months since prior neoadjuvant chemotherapy
  • No prior adjuvant chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy


  • Not specified


  • No other concurrent clinical trial participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077220

  Show 68 Study Locations
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
OverallOfficial: Jean F. Morere, MD Hopital Avicenne

ClinicalTrials.gov Identifier: NCT00077220     History of Changes
Other Study ID Numbers: CDR0000350015
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action