Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-02 @ 12:26 AM
Study NCT ID:
NCT02228356
Status:
UNKNOWN
Last Update Posted:
2016-05-11
First Post:
2014-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
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:
The investigators recently published 2 phase II trials on the use of helical tomotherapy for oligometastatic colorectal cancer \[1,2\]. Despite a dose increase from 40 to 50 Gy, delivered in 2 weeks time, the one-year local control was 54% only \[1,2\]. The high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (BED) of \< 100 Gy. The current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated CT to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose, allowing higher doses in the tumor core. As the concept of an internal target volume (ITV) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BUN143201215117 | REGISTRY | UZ Brussel Ethics Committee | View |