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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002624
• Other study ID #: CALGB-9335
• Secondary ID: U10CA031946CDR00
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: December 1994
• Est. completion date: August 2005

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• adjuvant therapy

• diagnostic thoracoscopy

• therapeutic thoracoscopy

• video-assisted surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales
Peru	Instituto de Enfermedades Neoplasicas	Lima
Puerto Rico	San Juan City Hospital	San Juan
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	Iowa Lutheran Hospital	Des Moines	Iowa
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	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska
United States	Drexel University Hospital	Philadelphia	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

References & Publications (2)

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]

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)		Up to 10 years	No
Primary	Determine the incidence of locoregional recurrence in patients treated with this regimen		Up to 10 years	No
Primary	Determine the overall and disease-free survival		Up to 10 years	Yes
Primary	Determine the short- and long-term complications associated with VAR in these patients		Up to 10 years	No
Primary	Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients		Up to 10 years	No
Primary	Determine the toxicity of adjuvant radiotherapy after VAR in these patients		Up to 10 years	Yes