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Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors (FACPT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01105182
First received: April 12, 2010
Last updated: April 15, 2010
Last verified: December 2009
  Purpose

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).


Condition Intervention
NSCLC
Pulmonary Metastases
Procedure: Radiofrequency Ablation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: November 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Radiofrequency Ablation Procedure: Radiofrequency Ablation
Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
Other Name: WHK-3 RFA (Welfare Electronics Co., Beijing PR China)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with pulmonary malignancies are not candidates for surgical resectionpatients.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105182

Contacts
Contact: Weiqiang Yin, MD +86-20-833 37792 dryin2010@gmail.com
Contact: Daoyuan Wang, MD +86-20-833 37792 ghealth2008@gmail.com

Locations
China, Guangdong
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jianxing He, MD, FACS    +86-20-83337792    drjianxing.he@gmail.com   
Contact: Xin Xu, MD    +86-20-83337792    yichunrenjia@126.com   
Principal Investigator: Jianxing He, MD, FACS         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Medical College
ClinicalTrials.gov Identifier: NCT01105182     History of Changes
Other Study ID Numbers: FAHG20100201
Study First Received: April 12, 2010
Last Updated: April 15, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
Radiofrequency Ablation

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014