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

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
  • Peru
      • Lima, Peru, 34
        • Instituto De Enfermedades Neoplasicas
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-7344
        • San Juan City Hospital
  • United States
    • Colorado
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program, Incorporated
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50316-2301
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center at Mercy Medical Center-Des Moines
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Papillion, Nebraska, United States, 68128-4157
        • Midlands Cancer Center at Midlands Community Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Drexel University Hospital
      • Pittsburgh, Pennsylvania, United States, 15236
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Radiation: radiation therapy
Procedure: adjuvant therapy
Procedure: therapeutic thoracoscopy
Procedure: diagnostic thoracoscopy
Procedure: video-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Time Frame: Up to 10 years
Up to 10 years
Determine the incidence of locoregional recurrence in patients treated with this regimen
Time Frame: Up to 10 years
Up to 10 years
Determine the overall and disease-free survival
Time Frame: Up to 10 years
Up to 10 years
Determine the short- and long-term complications associated with VAR in these patients
Time Frame: Up to 10 years
Up to 10 years
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Time Frame: Up to 10 years
Up to 10 years
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Hani Shennib, MD, Montreal General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 1994

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-9335
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000063987 (Registry Identifier: NCI Physician Data Query)

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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