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

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Rob Van Klaveren, MD, PhD, University Medical Center Rotterdam at Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-08981

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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