Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors (FACPT)

A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Study Overview

• Status: Unknown
• Conditions: Pulmonary Metastases; NSCLC
• Intervention / Treatment: Procedure: Radiofrequency Ablation

Detailed Description

Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies. Recently, RFA has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary malignancies. Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response. We designed a prospective clinical trial aimed at assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the treatment of lung malignancies.

• Study Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
      • Contact: Jianxing He, MD, FACS; Phone Number: +86-20-83337792; Email: drjianxing.he@gmail.com
      • Principal Investigator: Jianxing He, MD, FACS
      • Contact: Xin Xu, MD; Phone Number: +86-20-83337792; Email: yichunrenjia@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with pulmonary malignancies are not candidates for surgical resectionpatients.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
• patient has more than 3 tumors / lung
• patient has at least one tumor > 6 cm in greatest diameter
• tumor is associated with atelectasis or obstructive pneumonitis
• patient has renal failure requiring hemodialysis or peritoneal dialysis
• patient has active clinically serious infection
• patient has history of organ allograft
• 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
• patient is pregnant or breast-feeding
• patient has ECOG performance status > 2
• patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiofrequency Ablation	Procedure: Radiofrequency Ablation; Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.; Other Names: WHK-3 RFA (Welfare Electronics Co., Beijing PR China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	30 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Jianxing He, MD, FACS, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2010
• Last Update Submitted That Met QC Criteria: April 15, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: FAHG20100201