Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

• Sponsor: Karen-Lise Garm Spindler (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05385250
• Collaborator: Herlev Hospital (Other), Zealand University Hospital (Other), Vejle Hospital (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 54.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anal Cancer; Radiotherapy Side Effect	Other: Bone sparring radiotherapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A phase II prospective observational clinical trialA phase II prospective observational clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial. Danish Anal Cancer Group Study
• Actual Study Start Date: Aug 23, 2021
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of PIFs [1 year]

   Rate of pelvic insufficience fractures (PIF) on MRI

Secondary Outcome Measures

1. Rate of symptomatic PIFs [after 1 and 3 year]

   Rate of symptomatic Pelvic insufficiency fractures (PIF)

2. 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

3. Predictive and prognostic biomarkers [Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years]

   Correlation between levels of circulating DNA (copies per ML) in blood samples and outcomes

4. Patient reported outcomes measures (LARS) [Pretreatment and after 1 and 3 years]

   Patient reported outcome measure by LARS (low anterior resection syndrome) scores

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

6. Quality of Life measures (EORTC) [Pretreatment and after 1 and 3 years]

   Quality of Life measures (EORTC)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8200

Sponsors and Collaborators

• Karen-Lise Garm Spindler
• Herlev Hospital
• Zealand University Hospital
• Vejle Hospital

Investigators

• Study Chair: Karen-Lise G Spindler, DMSc, PhD, Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen-Lise Garm Spindler, Professor, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT05385250
• Other Study ID Numbers: DACG-II
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anus Neoplasms

Study Results

No Results Posted as of May 23, 2022