VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
adjuvant therapy
+ diagnostic thoracoscopy
+ therapeutic thoracoscopy
Adenocarcinoma+13
+ Bronchial Neoplasms
+ Carcinoma
Treatment Study
Summary
Study start date: December 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.66 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
CCOP - Colorado Cancer Research Program, Incorporated
Denver, United StatesOpen CCOP - Colorado Cancer Research Program, Incorporated in Google MapsJohn Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, United StatesMercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, United StatesIowa Lutheran Hospital
Des Moines, United States