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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00690703




Registration number
NCT00690703
Ethics application status
Date submitted
3/06/2008
Date registered
5/06/2008
Date last updated
5/06/2008

Titles & IDs
Public title
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation
Scientific title
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
Secondary ID [1] 0 0
102-00
Universal Trial Number (UTN)
Trial acronym
RAPTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Pulmonary Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - RF ablation (Rita Medical Systems Model 1500x)

Experimental: 1 - Treatment


Treatment: Devices: RF ablation (Rita Medical Systems Model 1500x)
computed tomography-guided RF ablation with an expandable electrode needle
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
technical success
Timepoint [1] 0 0
immediate
Primary outcome [2] 0 0
complications
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
pulmonary function
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
tumor response
Timepoint [4] 0 0
1 years
Secondary outcome [1] 0 0
overall survival
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
cancer-specific survival
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
quality of life
Timepoint [3] 0 0
2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2052 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Germany
State/province [2] 0 0
Essen
Country [3] 0 0
Germany
State/province [3] 0 0
Muenchen
Country [4] 0 0
Italy
State/province [4] 0 0
Candiolo
Country [5] 0 0
Italy
State/province [5] 0 0
Pisa
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Angiodynamics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective
treatment for malignant lung tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00690703
Trial related presentations / publications
Lencioni R, Cioni D, Crocetti L, Franchini C, Pina CD, Lera J, Bartolozzi C. Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation. Radiology. 2005 Mar;234(3):961-7. doi: 10.1148/radiol.2343040350. Epub 2005 Jan 21.
Tateishi R, Shiina S, Teratani T, Obi S, Sato S, Koike Y, Fujishima T, Yoshida H, Kawabe T, Omata M. Percutaneous radiofrequency ablation for hepatocellular carcinoma. An analysis of 1000 cases. Cancer. 2005 Mar 15;103(6):1201-9. doi: 10.1002/cncr.20892.
Miao Y, Ni Y, Bosmans H, Yu J, Vaninbroukx J, Dymarkowski S, Zhang H, Marchal G. Radiofrequency ablation for eradication of pulmonary tumor in rabbits. J Surg Res. 2001 Aug;99(2):265-71. doi: 10.1006/jsre.2001.6208.
Pennathur A, Luketich JD, Abbas G, Chen M, Fernando HC, Gooding WE, Schuchert MJ, Gilbert S, Christie NA, Landreneau RJ. Radiofrequency ablation for the treatment of stage I non-small cell lung cancer in high-risk patients. J Thorac Cardiovasc Surg. 2007 Oct;134(4):857-64. doi: 10.1016/j.jtcvs.2007.04.060. Epub 2007 Aug 29.
Simon CJ, Dupuy DE, DiPetrillo TA, Safran HP, Grieco CA, Ng T, Mayo-Smith WW. Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients. Radiology. 2007 Apr;243(1):268-75. doi: 10.1148/radiol.2431060088.
Public notes

Contacts
Principal investigator
Name 0 0
Riccardo Lencioni, MD
Address 0 0
University of Pisa, Pisa, Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00690703