Non Small Cell Lung CancerPhase 2RAPTURENCT00690703
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation
A Phase 2 study testing RF ablation (Rita Medical Systems Model 1500x) in people with Non Small Cell Lung Cancer and Pulmonary Metastases, run by Angiodynamics, Inc. at 7 sites in 5 countries.
Trial summary
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Pulmonary Metastases
- What is being tested?
- RF ablation (Rita Medical Systems Model 1500x)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Jul 2001to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 or chemotherapy
- patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, 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
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- 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.
Who cannot join
- patient has undergone previous pneumonectomy
- 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 > 3.5 in greatest diameter
- tumor is associated with atelectasis or obstructive pneumonitis
- patient has renal failure requiring hemodialysis or peritoneal dialysis
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- 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.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany2 sites
University Hospital Essen
Essen, 45122
Ludwig-Maximilians University
München, 82152
Italy2 sites
Institute for Cancer Research and Treatment
Candiolo, 10060
University of Pisa
Pisa, 56100
About this study
Official title: Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
Read the detailed 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.
- Conditions
- Non Small Cell Lung Cancer, Pulmonary Metastases
- Being tested
- RF ablation (Rita Medical Systems Model 1500x)
- Keywords
- non small cell lung cancer, pulmonary metastases, radiofrequency ablation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablation (Rita Medical Systems Model 1500x)Device
Also called Rita Medical Systems Model 1500x, Rita Medical Systems Starburst XL
computed tomography-guided RF ablation with an expandable electrode needle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Receives: Device: RF ablation (Rita Medical Systems Model 1500x) |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success
Measured: immediate
complications
Measured: 30 days
pulmonary function
Measured: 2 years
tumor response
Measured: 1 years
Secondary outcomes (3)
overall survival
Measured: 2 years
cancer-specific survival
Measured: 2 years
quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJul 2001
- Primary completionDec 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Riccardo Lencioni, MD, Principal investigator, University of Pisa, Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690703
- Sponsor's protocol ID
- 102-00
- Acronym
- RAPTURE
- Status last verified
- Jun 2008
- First submitted
- 3 Jun 2008
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15665226Tateishi 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.
PubMed 15690326Miao 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.
PubMed 11469896Pennathur 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.
PubMed 17903496Simon 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.
PubMed 17392258Lencioni R, Crocetti L, Cioni R, Suh R, Glenn D, Regge D, Helmberger T, Gillams AR, Frilling A, Ambrogi M, Bartolozzi C, Mussi A. Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study). Lancet Oncol. 2008 Jul;9(7):621-8. doi: 10.1016/S1470-2045(08)70155-4. Epub 2008 Jun 17.
PubMed 18565793
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT00690703
- Acronym / sponsor ID
- RAPTURE / 102-00
- Conditions
- Non Small Cell Lung Cancer, Pulmonary Metastases
- Keywords
- non small cell lung cancer, pulmonary metastases, radiofrequency ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: RF ablation (Rita Medical Systems Model 1500x)Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 or chemotherapy
- patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
- tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
Key exclusion criteria (12 listed)
- patient has undergone previous pneumonectomy
- 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 > 3.5 in greatest diameter
- tumor is associated with atelectasis or obstructive pneumonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF ablation (Rita Medical Systems Model 1500x)Also: Rita Medical Systems Model 1500x, Rita Medical Systems Starburst XLcomputed tomography-guided RF ablation with an expandable electrode needle | Device | 1 |
Primary outcome
technical success
Time frame: immediate
complications
Time frame: 30 days
pulmonary function
Time frame: 2 years
tumor response
Time frame: 1 years
3 secondary outcomes
overall survival
Time frame: 2 years
cancer-specific survival
Time frame: 2 years
quality of life
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
- Background: PubMed 15665226Lencioni 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.
- Background: PubMed 15690326Tateishi 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.
- Background: PubMed 11469896Miao 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.
- Background: PubMed 17903496Pennathur 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.
- Background: PubMed 17392258Simon 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.
- Derived from this study: PubMed 18565793Lencioni R, Crocetti L, Cioni R, Suh R, Glenn D, Regge D, Helmberger T, Gillams AR, Frilling A, Ambrogi M, Bartolozzi C, Mussi A. Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study). Lancet Oncol. 2008 Jul;9(7):621-8. doi: 10.1016/S1470-2045(08)70155-4. Epub 2008 Jun 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Lencioni, MD principal investigator
University of Pisa, Pisa, Italy
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RF ablation (Rita Medical Systems Model 1500x) in people with Non Small Cell Lung Cancer and Pulmonary Metastases, run by Angiodynamics, Inc. at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success (time frame: immediate). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00690703, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2008.