Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Malignant Mesothelioma; Lung Cancer; Thymoma and Thymic Carcinoma

Treatments: Procedure: radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00024076

UCLA-9908024

NCI-G01-2011

CDR0000068889

Details and patient eligibility

About

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Full description

OBJECTIVES:

• Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
• Determine the efficacy of this treatment, in terms of local control, in these patients.
• Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.

OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.

Patients are followed at 1, 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of a primary or secondary intrathoracic malignancy

  • Any cell type or origin
  • Involving the intrapulmonary, mediastinal, or pleural/chest wall
  • Inoperable primary or metastatic cancer to the lung

• Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)

• Single or multiple lesions that are non-contiguous with vital structures or organs such as:

• Trachea

• Heart

• Aorta

• Great vessels

• Esophagus

• Less than 5 cm in largest dimension

• Accessible via percutaneous transthoracic route

• Hepatic:

  • Coagulation profile normal

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)