Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-30 @ 3:52 AM
Study NCT ID:
NCT01767935
Status:
TERMINATED
Last Update Posted:
2018-11-14
First Post:
2013-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accruals
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 cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.
OUTLINE:
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.
I. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.
OUTLINE:
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02087 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |
| CCCWFU 97212 | OTHER | Wake Forest University Health Sciences | View |