Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

NCT05385250 | Active Not Recruiting

• 1 other identifier: DACG-II
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Rate of PIFs

  Rate of pelvic insufficience fractures (PIF) on MRI

  1 year

Secondary Outcomes (6)

• Rate of symptomatic PIFs

  after 1 and 3 year

• Rate of toxicity from standard organs at risk (OAR)

  after 1 and 3 years

• Predictive and prognostic biomarkers

  Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years

• Patient reported outcomes measures (LARS)

  Pretreatment and at 1 and 3 years

• Patient reported outcome measures (FACT-BP)

  Pretreatment and after 1 and 3 years

Study Arms (1)

Bone sparring radiotherapy

OTHER

Observational arm of bone-sparing radiotherapy

Other: Bone sparring radiotherapy

Interventions

Bone sparring radiotherapy OTHER

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

Bone sparring radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karen-Lise Garm Spindler: lead
• Herlev Hospital: collaborator
• Zealand University Hospital: collaborator
• Vejle Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Anus Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Wounds and Injuries

Study Officials

• Karen-Lise G Spindler, DMSc, PhD

  Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A phase II prospective observational clinical trial

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: May 23, 2022
• Study Start: August 23, 2021
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)