NCT05385250

Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial Danish Anal Cancer Group Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Karen-Lise Garm Spindler · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Cancer
• Radiotherapy Side Effect

Interventions

Type	Name	Description
OTHER	Bone sparring radiotherapy	Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer

Timeline

• Start date: 2021-08-23
• Primary completion: 2025-01-01
• Completion: 2026-03-01
• First posted: 2022-05-23
• Last updated: 2024-08-15

Locations

1 site across 1 country: Denmark