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

This study has been terminated.
(low accrual)
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: July 11, 2001
Last updated: July 17, 2012
Last verified: July 2012

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
Radiation: radiation therapy
Phase 2

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

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 5
Study Start Date: April 2001
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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
University Hospital - Rotterdam Dijkzigt
Rotterdam, Netherlands, 3000 CA
Rotterdam Cancer Institute
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
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00021112     History of Changes
Other Study ID Numbers: EORTC-08981, EORTC-08981
Study First Received: July 11, 2001
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic processed this record on April 17, 2014