Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT01811394
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2013-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ion Irradiation of Sacrococcygeal Chordoma
Sponsor:
Heidelberg University
Organization:
Study Overview
Official Title:
Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
ACTIVE_NOT_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:
ISAC
Brief Summary:
The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.
Detailed Description:
The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.
Study Oversight
Has Oversight DMC:
True
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?: