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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CDR0000063987 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + surgery | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy | Procedure |
| ||
| diagnostic thoracoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) | Up to 10 years | |
| Determine the incidence of locoregional recurrence in patients treated with this regimen | Up to 10 years | |
| Determine the overall and disease-free survival | Up to 10 years | |
| Determine the short- and long-term complications associated with VAR in these patients | Up to 10 years | |
| Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients | Up to 10 years | |
| Determine the toxicity of adjuvant radiotherapy after VAR in these patients | Up to 10 years |
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DISEASE CHARACTERISTICS:
Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor
Tumor must not be identifiable by bronchoscopy
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:
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:
Cytology from bronchial washings and transthoracic needle aspiration not acceptable
PATIENT CHARACTERISTICS:
Age:
Performance status:
Other:
PRIOR CONCURRENT THERAPY:
Radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Hani Shennib, MD | Montreal General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado | 80224 | United States | ||
| John Stoddard Cancer Center at Iowa Methodist Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15821648 | Result | Shennib H, Bogart J, Herndon JE, Kohman L, Keenan R, Green M, Sugarbaker D; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group. Video-assisted wedge resection and local radiotherapy for peripheral lung cancer in high-risk patients: the Cancer and Leukemia Group B (CALGB) 9335, a phase II, multi-institutional cooperative group study. J Thorac Cardiovasc Surg. 2005 Apr;129(4):813-8. doi: 10.1016/j.jtcvs.2004.05.011. | |
| Result | Bogart J, Shennib H, Kohman L, et al.: Radiotherapy following thorascopic wedge resection (TWR) of T1 non-small cell lung cancer (NSCLC) in high risk patients: a Cancer and Leukemia Group B and Eastern Cooperative Oncology Group Phase II Trial. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1907, 2000. |
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| Procedure |
|
| therapeutic thoracoscopy | Procedure |
|
| video-assisted surgery | Procedure |
|
| radiation therapy | Radiation |
|
| Des Moines |
| Iowa |
| 50309 |
| United States |
| Mercy Cancer Center at Mercy Medical Center-Des Moines | Des Moines | Iowa | 50314 | United States |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316-2301 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Midlands Cancer Center at Midlands Community Hospital | Papillion | Nebraska | 68128-4157 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Drexel University Hospital | Philadelphia | Pennsylvania | 19102-1192 | United States |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15236 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54307-3453 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Instituto de Enfermedades Neoplasicas | Lima | 34 | Peru |
| San Juan City Hospital | San Juan | 00936-7344 | Puerto Rico |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D020535 | Video-Assisted Surgery |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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