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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00002624

CDR0000063987 (Registry Identifier)

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-9335

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Radiotherapy + surgery

Experimental group

Description:

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.

Treatment:

Radiation: radiation therapy

Procedure: adjuvant therapy

Procedure: diagnostic thoracoscopy

Procedure: video-assisted surgery

Procedure: therapeutic thoracoscopy