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

NCT00002624 | Completed Phase 2

• 3 other identifiers: CALGB-9335U10CA031946CDR0000063987
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (6)

• Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)

  Up to 10 years

• Determine the incidence of locoregional recurrence in patients treated with this regimen

  Up to 10 years

• Determine the overall and disease-free survival

  Up to 10 years

• Determine the short- and long-term complications associated with VAR in these patients

  Up to 10 years

• Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients

  Up to 10 years

• Determine the toxicity of adjuvant radiotherapy after VAR in these patients

  Up to 10 years

Study Arms (1)

Radiotherapy + surgery

EXPERIMENTAL

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.

Procedure: adjuvant therapy; Procedure: diagnostic thoracoscopy; Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery; Radiation: radiation therapy

Interventions

adjuvant therapy PROCEDURE

Radiotherapy + surgery

diagnostic thoracoscopy PROCEDURE

Radiotherapy + surgery

therapeutic thoracoscopy PROCEDURE

Radiotherapy + surgery

video-assisted surgery PROCEDURE

Radiotherapy + surgery

radiation therapy RADIATION

Radiotherapy + surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Cancer Center at Mercy Medical Center-Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Midlands Cancer Center at Midlands Community Hospital

Papillion, Nebraska, 68128-4157, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Drexel University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15236, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

San Juan City Hospital

San Juan, 00936-7344, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 15821648 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Chemotherapy, Adjuvant; Video-Assisted Surgery; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hani Shennib, MD

  Montreal General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: December 1, 1994
• Primary Completion: April 1, 2005
• Study Completion: August 1, 2005
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

PE (1); PR (1); AU (1); US (13)