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)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00021112
First received: July 11, 2001
Last updated: July 17, 2012
Last verified: July 2012
  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
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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Poland
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
Investigators
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
ClinicalTrials.gov 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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014