Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

Non-small Cell Lung Cancer Clinical Trial

— NSCLC  

Official title:

A Pilot Study of Interventional Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01028612
• Other study ID #: IRB00011975
• Secondary ID: CCCWFU 62109
• Status: Terminated
• Phase: N/A
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days) for patients with early stage lung cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with AJCC sixth edition Stage Ib or II non-small-cell lung cancer with cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible.

• To be considered node negative for N2 disease, patients will have mediastinal lymph nodes = 1.5 cm and no clinically suspicious uptake on FDG PET in those areas.

• All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to co-morbid conditions.

• The CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion is determined to be in a location where RFA is technically achievable based on the proximity of adjacent organs and structures.

• Age = 18 years old

• Performance Status 0-2 (ECOG)

Exclusion Criteria:

• 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 of < 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 entry

• Previous chest radiation to the region of interest.

• Pregnant or lactating women.

• A clinical diagnosis of bronchoalveolar carcinoma (BAC) will be made for patients in whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the following radiographic criteria are met.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• thermal ablation with external beam radiation
thermal ablation with external beam radiation

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days).		2 years