Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002624
First received: November 1, 1999
Last updated: March 17, 2010
Last verified: February 2004
  Purpose

RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment in patients whose poor heart and lung function make them high risk for standard surgery.

PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function.


Condition Intervention Phase
Lung Cancer
Procedure: adjuvant therapy
Procedure: diagnostic thoracoscopy
Procedure: therapeutic thoracoscopy
Procedure: video-assisted surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY

Resource links provided by NLM:


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

Estimated Enrollment: 66
Study Start Date: December 1994
Detailed Description:

OBJECTIVES:

  • Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) followed by radiotherapy in patients with stage I non-small cell lung cancer and cardiopulmonary dysfunction.
  • Determine the incidence of locoregional recurrence in patients treated with this regimen.
  • Determine the overall and disease-free survival in patients treated with this regimen.
  • Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients.
  • Determine the incidence of conversion to open thoracotomy in these patients.
  • Determine the short- and long-term complications associated with VAR in these patients.
  • Determine the toxicity of adjuvant radiotherapy after VAR in these patients.

OUTLINE: This is a multicenter study.

Patients undergo video-assisted thoracoscopic wedge resection. Surgeons attempt sampling and identification of all ipsilateral, mediastinal, and hilar lymph nodes. When accessible, lobar lymph nodes must also be sampled. If the tumor margins are positive, further resection of the margins must be attempted. Open thoracotomy may be required for technical reasons.

Eligible patients begin radiotherapy 2-8 weeks postoperatively. Patients with complete resection undergo radiotherapy 5 days a week for 5.6 weeks. Patients with incomplete resection undergo radiotherapy 5 days a week for 6.6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 66 patients will be accrued for this study within approximately 22 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor

    • Tumor must not be identifiable by bronchoscopy

      • Bronchoscopically visible cancer or bronchial distortions considered related to tumor
    • Positive cytology by bronchoscopy allowed if no gross abnormality visible
    • Mediastinoscopy required for nodes greater than 1 cm
    • No pleural effusions
    • No metastatic or N2 disease on CT scan
    • Lesion must be accessible for video-assisted thoracoscopic wedge resection
  • High cardiopulmonary risk for thoracotomy with at least 1 of the following criteria:

    • FEV1 less than 40% predicted
    • DLCO less than 50% predicted
    • Supplemental oxygen requirement
    • Chronic PaCO2 greater than 45 mm Hg
    • Maximum oxygen consumption (VO2 max) less than 15 mL/kg/min
  • Patients who appear at high risk for non-pulmonary reasons (e.g., patients who are elderly or with renal or cardiac failure) may be eligible only if VO2 max or other criteria above are met
  • Eligible for radiotherapy after completion of wedge resection if histologic documentation of non-small cell lung cancer, including any of the following subtypes:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Bronchoalveolar cell
    • Large cell anaplastic carcinoma
  • Cytology from bronchial washings and transthoracic needle aspiration not acceptable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • See Disease Characteristics

Cardiovascular:

  • See Disease Characteristics

Pulmonary:

  • See Disease Characteristics

Other:

  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Weight loss no greater than 10% within the past 6 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior thoracic irradiation

Surgery

  • Not specified
  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: NCT00002624

Locations
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Iowa
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, United States, 50314
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Drexel University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Peru
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Sponsors and Collaborators
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Investigators
Study Chair: Hani Shennib, MD Montreal General Hospital
Study Chair: Robert J. Keenan, MD Allegheny Cancer Center at Allegheny General Hospital
  More Information

Additional Information:
Publications:
Bogart J, Shennib H, Kohman L, et al.: Radiotherapy following thorascopic wedge resection (TWR) of T1 non-small cell lung cancer (NSCLC) in high risk patients: a Cancer and Leukemia Group B and Eastern Cooperative Oncology Group Phase II Trial. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1907, 2000.

ClinicalTrials.gov Identifier: NCT00002624     History of Changes
Other Study ID Numbers: CDR0000063987, CALGB-9335, ECOG-C9335
Study First Received: November 1, 1999
Last Updated: March 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar 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

ClinicalTrials.gov processed this record on July 31, 2014