Clinical trial NCT00002624: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
timeFrame: Up to 10 years
measure: Determine the incidence of locoregional recurrence in patients treated with this regimen
timeFrame: Up to 10 years
measure: Determine the overall and disease-free survival
timeFrame: Up to 10 years
measure: Determine the short- and long-term complications associated with VAR in these patients
timeFrame: Up to 10 years
measure: Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
timeFrame: Up to 10 years
measure: Determine the toxicity of adjuvant radiotherapy after VAR in these patients
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: CCOP - Colorado Cancer Research Program, Incorporated
state: Colorado
city: Des Moines
country: United States
facility: John Stoddard Cancer Center at Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Cancer Center at Mercy Medical Center-Des Moines
state: Iowa
city: Des Moines
country: United States
facility: Iowa Lutheran Hospital
state: Iowa
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Papillion
country: United States
facility: Midlands Cancer Center at Midlands Community Hospital
state: Nebraska
city: Albuquerque
country: United States
facility: MBCCOP - University of New Mexico HSC
state: New Mexico
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center at University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Lima
country: Peru
facility: Instituto de Enfermedades Neoplasicas
city: San Juan
country: Puerto Rico
facility: San Juan City Hospital
Study officials:
affiliation: Montreal General Hospital
name: Hani Shennib, MD
role: STUDY_CHAIR
References:
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. doi: 10.1016/j.jtcvs.2004.05.011.
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.