Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 1994 |
End Date: | August 2005 |
VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
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.
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.
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.
- 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.
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
We found this trial at
14
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