Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
- Conditions
- Lung Cancer
- Interventions
- Procedure: adjuvant therapyProcedure: diagnostic thoracoscopyProcedure: therapeutic thoracoscopyProcedure: video-assisted surgeryRadiation: radiation therapy
- Registration Number
- NCT00002624
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiotherapy + surgery diagnostic thoracoscopy 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. Radiotherapy + surgery radiation therapy 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. Radiotherapy + surgery adjuvant therapy 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. Radiotherapy + surgery therapeutic thoracoscopy 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. Radiotherapy + surgery video-assisted 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.
- Primary Outcome Measures
Name Time Method Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients Up to 10 years Determine the short- and long-term complications associated with VAR in these patients Up to 10 years Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) Up to 10 years Determine the overall and disease-free survival Up to 10 years Determine the toxicity of adjuvant radiotherapy after VAR in these patients Up to 10 years Determine the incidence of locoregional recurrence in patients treated with this regimen Up to 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center-Des Moines
🇺🇸Des Moines, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Midlands Cancer Center at Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Drexel University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Instituto de Enfermedades Neoplasicas
🇵🇪Lima, Peru
San Juan City Hospital
🇵🇷San Juan, Puerto Rico