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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Hani Shennib, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montreal General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000063987

NCT ID:

NCT00002624

Start Date:

December 1994

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Mercy Cancer Center at Mercy Medical Center-Des Moines Des Moines, Iowa  50314
Midlands Cancer Center at Midlands Community Hospital Papillion, Nebraska  68128-4157
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Drexel University Hospital Philadelphia, Pennsylvania  19102-1192
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236