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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
This study is ongoing, but not recruiting participants.
First Received: February 10, 2004   Last Updated: February 6, 2009   History of Changes
Sponsor: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077220
  Purpose

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 Intervention Phase
Lung Cancer
 Drug: carboplatin
Drug: paclitaxel
Procedure: adjuvant therapy
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel Carboplatin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: June 2002
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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077220

  Show 68 Study Locations
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Investigator: Jean F. Morere, MD Hopital Avicenne
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000350015, FRE-GERCOR-B00-1, EU-20330
Study First Received: February 10, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00077220     History of Changes
Health Authority: United States: Federal Government

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:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Adjuvants, Immunologic
Antimitotic Agents
Carboplatin
Pharmacologic Actions
 Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009



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