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.
Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Procedure: adjuvant therapy; Procedure: diagnostic thoracoscopy; Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado
- John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa
- Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa
- Iowa Lutheran HospitalDes Moines, Iowa
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- CCOP - Metro-MinnesotaSaint Louis Park, Minnesota
- Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska
- MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico
- Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania
- Drexel University HospitalPhiladelphia, Pennsylvania
- Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania
- CCOP - MainLine HealthWynnewood, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.