Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

NCT01105182 | Unknown DMC

• 1 other identifier: FAHG20100201
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

NSCLC; Pulmonary Metastases

Keywords

Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  3 months

Secondary Outcomes (2)

• Overall survival

  3 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  30 days

Study Arms (1)

Radiofrequency Ablation

Procedure: Radiofrequency Ablation

Interventions

Radiofrequency Ablation PROCEDURE

Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.

Also known as: WHK-3 RFA (Welfare Electronics Co., Beijing PR China)

Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pulmonary malignancies are not candidates for surgical resectionpatients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jianxing He, MD, FACS

  Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiqiang Yin, MD

CONTACT

+86-20-833 37792; dryin2010@gmail.com

Daoyuan Wang, MD

CONTACT

+86-20-833 37792; ghealth2008@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 16, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: April 16, 2010

Record last verified: 2009-12

Locations

CN (1)