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

Sponsor:	Cancer and Leukemia Group B
Collaborators:	National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002624

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: conventional surgery Procedure: thoracoscopic surgery Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

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

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
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Drexel University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
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

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	CDR0000063987, CALGB-9335, ECOG-C9335
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002624 History of Changes
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:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 09, 2009