Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anal Cancer, Radiotherapy Side Effect

Intervention / Treatment
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* Other: Bone sparring radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A phase II prospective observational clinical trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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 | 
| Patient reported outcomes measures (LARS) | Patient reported outcome measure by LARS (low anterior resection syndrome) scores | Pretreatment and 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 |