Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109876
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2005-05-03
Brief Title:
Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies how well radiofrequency ablation works in treating patients with stage IA non-small cell lung cancer Radiofrequency ablation uses high-frequency electric current to kill tumor cells Computed tomography CT-guided radiofrequency ablation may be a better treatment for non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess the overall 2-year survival rate after radiofrequency ablation RFA
SECONDARY OBJECTIVES
I To assess freedom from regional or distant recurrence II To assess freedom from local recurrence in the ablated lobe III To estimate the number of procedures deemed technical successes IV To evaluate procedure-specific morbidity and mortality V To explore the utility of immediate within 96 hours post-RFA positron emission tomography PET in predicting overall survival and local control
VI To explore the effect of RFA on both short-term 3 months post-RFA and long-term 24 months post-RFA pulmonary function
OUTLINE
A radiofrequency electrode is placed by CT guidance into the target tumor Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature 60 Celsius C Patients may receive 3 RFA treatments a total of 36 minutes to obtain the target temperature
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 1 year
I To assess the overall 2-year survival rate after radiofrequency ablation RFA
SECONDARY OBJECTIVES
I To assess freedom from regional or distant recurrence II To assess freedom from local recurrence in the ablated lobe III To estimate the number of procedures deemed technical successes IV To evaluate procedure-specific morbidity and mortality V To explore the utility of immediate within 96 hours post-RFA positron emission tomography PET in predicting overall survival and local control
VI To explore the effect of RFA on both short-term 3 months post-RFA and long-term 24 months post-RFA pulmonary function
OUTLINE
A radiofrequency electrode is placed by CT guidance into the target tumor Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature 60 Celsius C Patients may receive 3 RFA treatments a total of 36 minutes to obtain the target temperature
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACOSOG-Z4033 | None | None | None |
| CDR0000426417 | REGISTRY | NCI Physician Data Query | None |