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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| Zealand University Hospital | OTHER |
| Vejle Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone sparring radiotherapy | Other | Observational arm of bone-sparing radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone sparring radiotherapy | Other | Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of PIFs | Rate of pelvic insufficience fractures (PIF) on MRI | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen-Lise G Spindler, DMSc, PhD | Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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A phase II prospective observational clinical trial
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| 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 |
| 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 |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D014947 | Wounds and Injuries |