VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 66
- Locations
- 16
- Primary Endpoint
- Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status:
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: therapeutic thoracoscopy (Procedure)
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.
Intervention: video-assisted surgery (Procedure)
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.
Intervention: radiation therapy (Radiation)
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.
Intervention: adjuvant therapy (Procedure)
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.
Intervention: diagnostic thoracoscopy (Procedure)
Outcomes
Primary Outcomes
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Time Frame: Up to 10 years
Determine the short- and long-term complications associated with VAR in these patients
Time Frame: Up to 10 years
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Time Frame: Up to 10 years
Determine the overall and disease-free survival
Time Frame: Up to 10 years
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Time Frame: Up to 10 years
Determine the incidence of locoregional recurrence in patients treated with this regimen
Time Frame: Up to 10 years
Secondary Outcomes
No secondary outcomes reported