Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II (DACG-II)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anal Cancer; Radiotherapy Side Effect
• Intervention / Treatment: Other: Bone sparring 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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bone sparring radiotherapy; Observational arm of bone-sparing radiotherapy	Other: Bone sparring radiotherapy; Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of PIFs	Rate of pelvic insufficience fractures (PIF) on MRI	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of symptomatic PIFs	Rate of symptomatic Pelvic insufficiency fractures (PIF)	after 1 and 3 year
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
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
Quality of Life measures (EORTC)	Quality of Life measures (EORTC)	Pretreatment and after 1 and 3 years
Predictive and prognostic biomarkers	Prognostic value of levels of circulating DNA (copies per ML) in blood samples	Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years
Patient reported outcomes measures (LARS)	Patient reported outcome measure by LARS (low anterior resection syndrome) scores 1-5	Pretreatment and at 1 and 3 years

Collaborators and Investigators

• Sponsor: Karen-Lise Garm Spindler
• Collaborators: Zealand University Hospital; Herlev Hospital; Vejle Hospital
• Investigators: Study Chair: Karen-Lise G Spindler, DMSc, PhD, Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: DACG-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No