Lung CancerNCT01051037
Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways
A study testing Stereotactic Body Radiation and Radiofrequency Ablation in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Stereotactic Body Radiation and Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2010to 20 Dec 2017
- Phase
- Interventional
- 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
- Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy
- Tumors < 2 cm from trachea or zone of proximal bronchial tree (central tumors)
- Each tumor < 5 cm in size prior to treatment
- Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery
- Criterion for medical inoperability include:
- Overall clinical assessment at the UCLA thoracic tumor board
Show all 14Show fewer
- Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below:
- Modified ACOSOG Criteria for medical inoperability:
- Major Criteria: FEV1% < 50% or < 1L and DLCO < 50%
- Minor Criteria: Age > 75, FEV1 51-60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF < 40% or less), resting or exercise arterial pO2 < 55 mmHg, and pCO2 > 45 mmHg
- Age > 18 years old
- KPS > 70
- If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Prior thoracic radiation near the targets of interest
- More than 2 central tumor targets per patient
- Active infections requiring systemic antibiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways
The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.
- Conditions
- Lung Cancer
- Being tested
- Stereotactic Body Radiation, Radiofrequency Ablation
- Keywords
- lung tumors, central airways
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiationRadiation
Also called SBR
3 fraction of stereotactic body radiation therapy within 10 days.
Radiofrequency AblationRadiation
Also called RFA
Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up. Receives: Radiation: Stereotactic Body Radiation; Radiation: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA.
Measured: 3 years
Secondary outcomes (6)
Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.
Measured: 3 years
Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).
Measured: 3 years
Progression-free survival
Measured: 3 years
Overall survival
Measured: 3 years
Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury
Measured: 3 years
Concentration of serum VEGF as an early biomarker for response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study start8 Feb 2010
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
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.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Percy Lee, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051037
- Sponsor's protocol ID
- 09-08-026
- Other IDs
- 10-000656
- Status last verified
- Apr 2018
- First submitted
- 15 Jan 2010
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways
- ClinicalTrials.gov ID
- NCT01051037
- Acronym / sponsor ID
- 09-08-026
- Conditions
- Lung Cancer
- Keywords
- lung tumors, central airways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Feb 2010 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 18 Jan 2010 (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 purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: Stereotactic Body Radiation, Radiation: Radiofrequency AblationSubjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy
- Tumors < 2 cm from trachea or zone of proximal bronchial tree (central tumors)
- Each tumor < 5 cm in size prior to treatment
- Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery
- Criterion for medical inoperability include:
Key exclusion criteria (3 listed)
- Prior thoracic radiation near the targets of interest
- More than 2 central tumor targets per patient
- Active infections requiring systemic antibiotics
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 |
|---|---|---|
| Stereotactic Body RadiationAlso: SBR3 fraction of stereotactic body radiation therapy within 10 days. | Radiation | Arm 1 |
| Radiofrequency AblationAlso: RFASubject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT. | Radiation | Arm 1 |
Primary outcome
Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA.
Time frame: 3 years
6 secondary outcomes
Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.
Time frame: 3 years
Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury
Time frame: 3 years
Concentration of serum VEGF as an early biomarker for response
Time frame: 3 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 6 May 2019.
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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.
Percy Lee, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation and Radiofrequency Ablation in people with Lung Cancer, 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 14 inclusion and 3 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 6 May 2019. 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.
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?
Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA. (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 6 May 2019.