Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
NCT ID: NCT00002624
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
1994-12-31
2005-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiotherapy + surgery
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.
adjuvant therapy
diagnostic thoracoscopy
therapeutic thoracoscopy
video-assisted surgery
radiation therapy
Interventions
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adjuvant therapy
diagnostic thoracoscopy
therapeutic thoracoscopy
video-assisted surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Hani Shennib, MD
Role: STUDY_CHAIR
Montreal General Hospital
Locations
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CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University Hospital
Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Westmead Hospital
Westmead, New South Wales, Australia
Instituto de Enfermedades Neoplasicas
Lima, , Peru
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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References
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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.
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.
Other Identifiers
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CDR0000063987
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9335
Identifier Type: -
Identifier Source: org_study_id
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