Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-28 @ 7:05 PM
Study NCT ID:
NCT05385250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2022-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II
Sponsor:
Karen-Lise Garm Spindler
Organization:
Study Overview
Official Title:
Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial Danish Anal Cancer Group Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
DACG-II
Brief Summary:
This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients. the trial aim to lower the risk of bone damage, while adhering with the constrains to the bowel, bladder and other conventional Organs At Risk, and finally to describe the fraction of pelvic insufficiency fractures in patients treated with optimized radiotherapy.
Detailed Description:
Patients will receive standard (chemo)-radiotherapy according to national Danish Anal Cancer Group (DACG) guidelines, but the bone-sparing focus will be added to the algorithm for dose-constrains and planning objectives. A bone specific magnetic resonance scan will be performed at 1 year post treatment. Additional substudies include collection of blood samples for translational research purposes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: