NCT00499447

Brief Summary

RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started May 2007

Typical duration 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

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 1, 2013

Completed
Last Updated

May 8, 2019

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

July 10, 2007

Results QC Date

January 25, 2013

Last Update Submit

April 25, 2019

Conditions

Lung Cancer

Keywords

stage I non-small cell lung canceradenocarcinoma of the lungadenosquamous cell lung cancerlarge cell lung cancersquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Two Year Progression Free Survival Rate

    the number of patients surviving progression-free at two years.

    2 years

Study Arms (1)

Radiofrequency Ablation with External Beam Radiation

EXPERIMENTAL

Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy

Procedure: radiofrequency ablationRadiation: radiation therapy

Interventions

radiofrequency ablationPROCEDURE
Radiofrequency Ablation with External Beam Radiation
radiation therapyRADIATION
Radiofrequency Ablation with External Beam Radiation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0-2
  • Women of childbearing potential must have a negative pregnancy test
  • Fertile women must use effective contraception

You may not qualify if:

  • History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA level \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to study entry
  • Pregnant or lactating women
  • PRIOR CONCURRENT THERAPY:
  • Previous chest radiation to the lung or mediastinum
  • Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
  • Radiotherapy
  • Radiofrequency ablation
  • Other antineoplastic interventional radiology techniques
  • Chemotherapy
  • Biological therapy
  • Vaccine therapy
  • Surgery
  • Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

Radiofrequency AblationRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Limitations and Caveats

adverse events were tracked in two cycles, one during treatment and one longer term

Results Point of Contact

Title
Dr. James Urbanic
Organization
Comprehensive Cancer Center of Wake Forest University
jurbanic@wakehealth.edu
336-713-3600

Study Officials

  • William Blackstock, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

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

July 10, 2007

First Posted

July 11, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 8, 2019

Results First Posted

March 1, 2013

Record last verified: 2016-03

Locations

US(1)