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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021112
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: etoposide Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Primary Purpose: Treatment
Official Title: Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
Study Start Date : April 2001
Actual Primary Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


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


  • 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


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


  • No clinical evidence of superior vena cava syndrome


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


  • 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


Biologic therapy:

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


  • No prior chemotherapy for NSCLC

Endocrine therapy:

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


  • No prior radiotherapy for NSCLC


  • No prior surgery for NSCLC


  • No other concurrent anticancer drugs during induction chemoradiotherapy

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 identifier (NCT number): NCT00021112

Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Thoraxklinik Rohrbach
Heidelberg, Germany, D-69126
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, Netherlands, 7334 DZ
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3000 CA
University Hospital - Rotterdam Dijkzigt
Rotterdam, Netherlands, 3000 CA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Medical University of Gdansk
Gdansk, Poland, 80-211
National Institute of Tuberculosis and Lung Diseases
Warsaw, Poland
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Rob Van Klaveren, MD, PhD University Medical Center Rotterdam at Erasmus Medical Center

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00021112     History of Changes
Other Study ID Numbers: EORTC-08981
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action