Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
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.
Procedure: adjuvant therapy
Procedure: diagnostic thoracoscopy
Procedure: therapeutic thoracoscopy
Procedure: video-assisted surgery
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY|
|Study Start Date:||December 1994|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002624
|United States, Colorado|
|CCOP - Colorado Cancer Research Program, Incorporated|
|Denver, Colorado, United States, 80224|
|United States, Iowa|
|Mercy Cancer Center at Mercy Medical Center-Des Moines|
|Des Moines, Iowa, United States, 50314|
|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|
|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|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Drexel University Hospital|
|Philadelphia, Pennsylvania, United States, 19102-1192|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15236|
|CCOP - MainLine Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, Wisconsin|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay|
|Green Bay, Wisconsin, United States, 54307-3453|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Instituto de Enfermedades Neoplasicas|
|Lima, Peru, 34|
|San Juan City Hospital|
|San Juan, Puerto Rico, 00936-7344|
|Study Chair:||Hani Shennib, MD||Montreal General Hospital|
|Study Chair:||Robert J. Keenan, MD||Allegheny Cancer Center at Allegheny General Hospital|