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Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021112
  Purpose

RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Etoposide    Cisplatin    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy

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

Study Start Date:   April 2001

Detailed Description:

OBJECTIVES:

  • Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
  • Determine the toxicity (morbidity and mortality) of this regimen in these patients.
  • Determine the clinical response rate and pathological response rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.

At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.

Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)

    • T4, any N, M0 or any T, N3, M0
    • No N3 disease due to scalene or supraclavicular lymph node involvement
  • No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement
  • No mixed tumor types with small cell lung cancer
  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
  • No pre-existing pleural or pericardial effusion
  • No CNS involvement by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm ^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.25 times ULN
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No clinical evidence of superior vena cava syndrome

Pulmonary:

  • Postoperative FEV1 and KCO greater than 40% predicted
  • VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)

Other:

  • No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma)
  • No active uncontrolled infection requiring IV antibiotics
  • No pre-existing sensory neurotoxicity grade 2 or greater
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for NSCLC
  • No concurrent immunotherapy during induction chemoradiotherapy
  • Concurrent colony stimulating factors allowed

Chemotherapy:

  • No prior chemotherapy for NSCLC

Endocrine therapy:

  • No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy

Radiotherapy:

  • No prior radiotherapy for NSCLC

Surgery:

  • No prior surgery for NSCLC

Other:

  • No other concurrent anticancer drugs during induction chemoradiotherapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021112

Locations
Belgium
Algemeen Ziekenhuis Middelheim    
      Antwerp, Belgium, 2020
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
Germany
Thoraxklinik Rohrbach    
      Heidelberg, Germany, D-69126
Netherlands
Gelre Ziekenhuizen - Lokatie Lukas    
      Apeldoorn, Netherlands, 7334 DZ
Academisch Ziekenhuis Utrecht    
      Utrecht, Netherlands, 3584 CX
Sint Antonius Ziekenhuis    
      Nieuwegein, Netherlands, 3435 CM
University Hospital - Rotterdam Dijkzigt    
      Rotterdam, Netherlands, 3000 CA
Rotterdam Cancer Institute    
      Rotterdam, Netherlands, 3000 CA
Poland
Medical University of Gdansk    
      Gdansk, Poland, 80-211
National Institute of Tuberculosis and Lung Diseases    
      Warsaw, Poland

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Rob Van Klaveren, MD, PhD     University Medical Center Rotterdam at Erasmus Medical Center    
  More Information


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

Study ID Numbers:   CDR0000068748, EORTC-08981
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00021112
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Etoposide phosphate
Etoposide
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 10, 2008




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