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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002624
First received: November 1, 1999
Last updated: July 12, 2016
Last verified: July 2016

November 1, 1999
July 12, 2016
December 1994
April 2005   (final data collection date for primary outcome measure)
  • Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Determine the incidence of locoregional recurrence in patients treated with this regimen [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Determine the overall and disease-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Determine the short- and long-term complications associated with VAR in these patients [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Determine the toxicity of adjuvant radiotherapy after VAR in these patients [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00002624 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Procedure: adjuvant therapy
  • Procedure: diagnostic thoracoscopy
  • Procedure: therapeutic thoracoscopy
  • Procedure: video-assisted surgery
  • Radiation: radiation therapy
Experimental: Radiotherapy + surgery

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.

Interventions:
  • Procedure: adjuvant therapy
  • Procedure: diagnostic thoracoscopy
  • Procedure: therapeutic thoracoscopy
  • Procedure: video-assisted surgery
  • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
August 2005
April 2005   (final data collection date for primary outcome measure)

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

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:

Radiotherapy

  • No prior thoracic irradiation
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Peru,   Puerto Rico
 
NCT00002624
CALGB-9335, U10CA031946, CDR0000063987
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Hani Shennib, MD Montreal General Hospital
Alliance for Clinical Trials in Oncology
July 2016

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