Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 1, 1999
March 17, 2010
December 1994
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002624 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Lung Cancer
  • Procedure: adjuvant therapy
  • Procedure: diagnostic thoracoscopy
  • Procedure: therapeutic thoracoscopy
  • Procedure: video-assisted surgery
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Peru,   Puerto Rico
 
NCT00002624
CDR0000063987, CALGB-9335, ECOG-C9335
Not Provided
Not Provided
Cancer and Leukemia Group B
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: Hani Shennib, MD Montreal General Hospital
Study Chair: Robert J. Keenan, MD Allegheny Cancer Center at Allegheny General Hospital
National Cancer Institute (NCI)
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP