Trial record 1 of 1 for:
NCT01051037
Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways
This study is currently recruiting participants.
Verified February 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Jonsson Comprehensive Cancer Center
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01051037
First received: January 15, 2010
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Radiation: Stereotactic Body Radiation Radiation: Radiofrequency Ablation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Concentration of serum VEGF as an early biomarker for response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.
|
Radiation: Stereotactic Body Radiation
3 fraction of stereotactic body radiation therapy within 10 days.
Other Name: SBR
Radiation: Radiofrequency Ablation
Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.
Other Name: RFA
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Prior thoracic radiation near the targets of interest
- More than 2 central tumor targets per patient
- Active infections requiring systemic antibiotics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051037
Contacts
| Contact: Percy Lee, MD | 310-206-6542 |
Locations
| United States, California | |
| UCLA Jonsson Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Percy Lee, MD 310-206-6542 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Principal Investigator: | Percy Lee, MD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01051037 History of Changes |
| Other Study ID Numbers: | 09-08-026 |
| Study First Received: | January 15, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
lung tumors central airways |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013