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Papillion, Nebraska 68128

  • Lung Cancer

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.


Study summary:

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.


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 is Available At:


Original ID:

CALGB-9335


NCT ID:

NCT00002624


Secondary ID:

U10CA031946


Study Acronym:


Brief Title:

Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function


Official Title:

VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

66


Enrollment Type:

Actual


Overall Contact Information

Official Name:Hani Shennib, MD
Study Chair
Montreal General Hospital

Study Dates

Start Date:December 1994
Completion Date:August 2005
Completion Type:Actual
Primary Completion Date:April 2005
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 12, 2016
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Time Frame:Up to 10 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine the incidence of locoregional recurrence in patients treated with this regimen
Time Frame:Up to 10 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine the overall and disease-free survival
Time Frame:Up to 10 years
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Determine the short- and long-term complications associated with VAR in these patients
Time Frame:Up to 10 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Time Frame:Up to 10 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Time Frame:Up to 10 years
Safety Issues:True

Study Interventions

Intervention Type:Procedure
Name:adjuvant therapy
Arm Name:Radiotherapy + surgery
Intervention Type:Procedure
Name:diagnostic thoracoscopy
Arm Name:Radiotherapy + surgery
Intervention Type:Procedure
Name:therapeutic thoracoscopy
Arm Name:Radiotherapy + surgery
Intervention Type:Procedure
Name:video-assisted surgery
Arm Name:Radiotherapy + surgery
Intervention Type:Radiation
Name:radiation therapy
Arm Name:Radiotherapy + surgery

Study Arms

Study Arm Type:Experimental
Arm Name:Radiotherapy + surgery
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:15821648
Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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