Radiofrequency Ablation of Pulmonary Tumors Response Evaluation (RAPTURE)

AngioDynamics

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer; Pulmonary Metastases

Treatments: Device: RF ablation (Rita Medical Systems Model 1500x)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690703

102-00

Details and patient eligibility

About

The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.

Full description

Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. adult (> 18 years) male or female patient
2. patient has biopsy-proven NSCLC or lung metastasis
3. patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
4. patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
5. tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
6. tumors are accessible by percutaneous route
7. patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
8. patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
9. patient has signed written informed consent prior to any study specific procedures.

Exclusion criteria

1. patient has undergone previous pneumonectomy
2. patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
3. patient has more than 3 tumors / lung
4. patient has at least one tumor > 3.5 in greatest diameter
5. tumor is associated with atelectasis or obstructive pneumonitis
6. patient has renal failure requiring hemodialysis or peritoneal dialysis
7. patient has active clinically serious infection
8. patient has history of organ allograft
9. patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
10. patient is pregnant or breast-feeding
11. patient has ECOG performance status > 2
12. patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

1

Experimental group

Description:

Treatment

Treatment:

Device: RF ablation (Rita Medical Systems Model 1500x)