Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-9335 ECOG-C9335, NCT00002624

Objectives

1. 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.
2. Determine the incidence of locoregional recurrence in patients treated with this regimen.
3. Determine the overall and disease-free survival in patients treated with this regimen.
4. Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients.
5. Determine the incidence of conversion to open thoracotomy in these patients.
6. Determine the short- and long-term complications associated with VAR in these patients.
7. Determine the toxicity of adjuvant radiotherapy after VAR in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior thoracic irradiation

Surgery

• Not specified

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

Expected Enrollment

Approximately 66 patients will be accrued for this study within approximately 22 months.

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.

Shennib H, Bogart J, Herndon JE, et al.: 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 129 (4): 813-8, 2005.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Hani Shennib, MD, Protocol chair(Contact information may not be current)		Ph: 514-934-1934, ext. 44327 Email: hani.shennib@mcgill.ca

Eastern Cooperative Oncology Group

Robert Keenan, MD, Protocol chair		Ph: 412-359-6202; 866-680-0004 Email: rkeenan@wpahs.org

Registry Information
Official Title		VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
Trial Start Date		1994-12-12
Registered in ClinicalTrials.gov		NCT00002624
Date Submitted to PDQ		1994-12-12
Information Last Verified		2004-02-27
NCI Grant/Contract Number		CA31946

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