Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

Karen-Lise Garm Spindler

Status

Active, not recruiting

Conditions

Radiotherapy Side Effect

Anal Cancer

Treatments

Other: Bone sparring radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05385250

DACG-II

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with biopsy verified localized squamous cell anal cancer
Indication for standard (chemo)-radiotherapy with curative intend for anal cancer as per multidisciplinary team decision
Clinical eligible for standard (chemo)-radiotherapy as per physicians' decision
Written and oral consent
Age at least 18 years

Exclusion criteria

Previous pelvic radiotherapy
Previous systemic therapy with severe bone marrow suppression or hematological diseases
Hip-replacements
Contraindications to MRI-scan