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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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
adjuvant therapy
diagnostic thoracoscopy
therapeutic thoracoscopy
video-assisted surgery
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Colorado Cancer Research Program, Incorporated
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Mercy Cancer Center at Mercy Medical Center-Des Moines
  • Iowa Lutheran Hospital
  • Beth Israel Deaconess Medical Center
  • CCOP - Metro-Minnesota
  • Midlands Cancer Center at Midlands Community Hospital
  • MBCCOP - University of New Mexico HSC
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Drexel University Hospital
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • CCOP - MainLine Health
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Westmead Hospital
  • Instituto de Enfermedades Neoplasicas
  • San Juan City Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy + surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002624
Brief Title
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
Official Title
VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 1994 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy + surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
diagnostic thoracoscopy
Intervention Type
Procedure
Intervention Name(s)
therapeutic thoracoscopy
Intervention Type
Procedure
Intervention Name(s)
video-assisted surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Time Frame
Up to 10 years
Title
Determine the incidence of locoregional recurrence in patients treated with this regimen
Time Frame
Up to 10 years
Title
Determine the overall and disease-free survival
Time Frame
Up to 10 years
Title
Determine the short- and long-term complications associated with VAR in these patients
Time Frame
Up to 10 years
Title
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Time Frame
Up to 10 years
Title
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hani Shennib, MD
Organizational Affiliation
Montreal General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Midlands Cancer Center at Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68128-4157
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Drexel University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
15821648
Citation
Shennib H, Bogart J, Herndon JE, Kohman L, Keenan R, Green M, Sugarbaker D; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group. Video-assisted wedge resection and local radiotherapy for peripheral lung cancer in high-risk patients: the Cancer and Leukemia Group B (CALGB) 9335, a phase II, multi-institutional cooperative group study. J Thorac Cardiovasc Surg. 2005 Apr;129(4):813-8. doi: 10.1016/j.jtcvs.2004.05.011.
Results Reference
result
Citation
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.
Results Reference
result

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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

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