Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

Not Applicable

Active, not recruiting

• Conditions: Anal Cancer; Radiotherapy Side Effect
• Interventions: Other: Bone sparring radiotherapy

• Registration Number: NCT05385250
• Lead Sponsor: Karen-Lise Garm Spindler

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 Timeline

• Study Start: 2021-08-23
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-01-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone sparring radiotherapy	Bone sparring radiotherapy	Observational arm of bone-sparing radiotherapy

Primary Outcome Measures

Name	Time	Method
Rate of PIFs	1 year	Rate of pelvic insufficience fractures (PIF) on MRI

Secondary Outcome Measures

Name	Time	Method
Rate of symptomatic PIFs	after 1 and 3 year	Rate of symptomatic Pelvic insufficiency fractures (PIF)
Predictive and prognostic biomarkers	Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years	Prognostic value of levels of circulating DNA (copies per ML) in blood samples
Rate of toxicity from standard organs at risk (OAR)	after 1 and 3 years	Rate of physician rated toxicity from standard OAR; bowel, bladder, skin
Patient reported outcomes measures (LARS)	Pretreatment and at 1 and 3 years	Patient reported outcome measure by LARS (low anterior resection syndrome) scores 1-5
Patient reported outcome measures (FACT-BP)	Pretreatment and after 1 and 3 years	Patient reported outcome measures by Functional Assessment of Cancer Therapy - Bone Pain score
Quality of Life measures (EORTC)	Pretreatment and after 1 and 3 years	Quality of Life measures (EORTC)

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark