Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size (NSCLC)
This study has been terminated.
(Slow accrual)
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01028612
First received: December 8, 2009
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Radiation: thermal ablation with external beam radiation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 1 |
| Study Start Date: | February 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: thermal ablation with external beam radiation |
Radiation: thermal ablation with external beam radiation
thermal ablation with external beam radiation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01028612 History of Changes |
| Other Study ID Numbers: | CCCWFU 62109 |
| Study First Received: | December 8, 2009 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013