Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Procedure: adjuvant therapy Procedure: diagnostic thoracoscopy Procedure: therapeutic thoracoscopy Procedure: video-assisted surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY |
| Estimated Enrollment: | 66 |
| Study Start Date: | December 1994 |
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.
Eligible 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.
PROJECTED ACCRUAL: Approximately 66 patients will be accrued for this study within approximately 22 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- See Disease Characteristics
Cardiovascular:
- See Disease Characteristics
Pulmonary:
- See Disease Characteristics
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:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior thoracic irradiation
Surgery
- Not specified
Contacts and Locations| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Incorporated | |
| Denver, Colorado, United States, 80224 | |
| United States, Iowa | |
| Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center-Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Nebraska | |
| Midlands Cancer Center at Midlands Community Hospital | |
| Papillion, Nebraska, United States, 68128-4157 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Drexel University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Peru | |
| Instituto de Enfermedades Neoplasicas | |
| Lima, Peru, 34 | |
| Puerto Rico | |
| San Juan City Hospital | |
| San Juan, Puerto Rico, 00936-7344 | |
| Study Chair: | Hani Shennib, MD | Montreal General Hospital |
| Study Chair: | Robert J. Keenan, MD | Allegheny Cancer Center at Allegheny General Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002624 History of Changes |
| Other Study ID Numbers: | CDR0000063987, CALGB-9335, ECOG-C9335 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 17, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I non-small cell lung cancer squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013