NCT01051037

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
21 days until next milestone

Study Start

First participant enrolled

February 8, 2010

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

May 6, 2019

Status Verified

April 1, 2018

Enrollment Period

7.9 years

First QC Date

January 15, 2010

Last Update Submit

May 3, 2019

Conditions

Lung Cancer

Keywords

lung tumorscentral airways

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (6)

  • Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.

    3 years

  • Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).

    3 years

  • Progression-free survival

    3 years

  • Overall survival

    3 years

  • Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury

    3 years

  • +1 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL

Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.

Radiation: Stereotactic Body RadiationRadiation: Radiofrequency Ablation

Interventions

Stereotactic Body RadiationRADIATION

3 fraction of stereotactic body radiation therapy within 10 days.

Also known as: SBR
Arm 1
Radiofrequency AblationRADIATION

Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.

Also known as: RFA
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior thoracic radiation near the targets of interest
  • More than 2 central tumor targets per patient
  • Active infections requiring systemic antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

RadiosurgeryRadiofrequency Ablation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesRadiofrequency TherapyAblation Techniques

Study Officials

  • Percy Lee, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

February 8, 2010

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

May 6, 2019

Record last verified: 2018-04

Locations

US(1)