Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Phase 2

Completed

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

• Registration Number: NCT00024076
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-12
• Status Verified: 2012-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States