Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

Anal Cancer Clinical Trial

— DACG-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385250
• Other study ID #: DACG-II
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2022
• Source: Aarhus University Hospital
• Contact: Garm Spindler, Professor
• Phone: +4591167244
• Email: k.g.spindler[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients. We seek 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Radiotherapy Side Effect

Intervention

Other:
• Bone sparring radiotherapy
Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
Karen-Lise Garm Spindler	Herlev Hospital, Vejle Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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