Lung CancerPhase 2NCT00024076
Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
A Phase 2 study testing radiofrequency ablation in people with Lung Cancer and Malignant Mesothelioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Malignant Mesothelioma, Metastatic Cancer
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Dec 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of a primary or secondary intrathoracic malignancy
- Any cell type or origin
- Involving the intrapulmonary, mediastinal, or pleural/chest wall
- Inoperable primary or metastatic cancer to the lung
- Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
- Single or multiple lesions that are non-contiguous with vital structures or organs such as:
Show all 15Show fewer
- Trachea
- Heart
- Aorta
- Great vessels
- Esophagus
- Less than 5 cm in largest dimension
- Accessible via percutaneous transthoracic route
- Hepatic:
- Coagulation profile normal
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Radiofrequency Ablation of Pulmonary Malignancy
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
- Determine the efficacy of this treatment, in terms of local control, in these patients.
- Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
Patients are followed at 1, 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Being tested
- radiofrequency ablation
- Keywords
- recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent malignant mesothelioma, recurrent thymoma and thymic carcinoma, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, pulmonary carcinoid tumor, lung metastases
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Malignant, Neoplasm Metastasis, Thymoma, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2000
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert D. Suh, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024076
- Sponsor's protocol ID
- CDR0000068889
- Other IDs
- UCLA-9908024, NCI-G01-2011
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2001
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Pulmonary Malignancy
- ClinicalTrials.gov ID
- NCT00024076
- Acronym / sponsor ID
- CDR0000068889
- Keywords
- recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent malignant mesothelioma, recurrent thymoma and thymic carcinoma, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, pulmonary carcinoid tumor, lung metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- Dec 2006 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.
Detailed description
OBJECTIVES:
- Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
- Determine the efficacy of this treatment, in terms of local control, in these patients.
- Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
Patients are followed at 1, 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of a primary or secondary intrathoracic malignancy
- Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
- Single or multiple lesions that are non-contiguous with vital structures or organs such as:
- Trachea
- Heart
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| radiofrequency ablation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 3 Aug 2020.
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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.
Robert D. Suh, MD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiofrequency ablation in people with Lung Cancer and Malignant Mesothelioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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 15 inclusion and 0 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Where can I read the original study information?
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 3 Aug 2020.