Anal Cancer, Radiotherapy Side Effect
Conditions
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.
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.
Interventions
OTHERBone sparring radiotherapy
Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer
Sponsors
Herlev Hospital
Zealand University Hospital
Vejle Hospital
Karen-Lise Garm Spindler
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A phase II prospective observational clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PIFs | 1 year | Rate of pelvic insufficience fractures (PIF) on MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Predictive and prognostic biomarkers | Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years | Prognostic value of levels of circulating DNA (copies per ML) in blood samples |
| Rate of symptomatic PIFs | after 1 and 3 year | Rate of symptomatic Pelvic insufficiency fractures (PIF) |
| 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 |
| Quality of Life measures (EORTC) | Pretreatment and after 1 and 3 years | Quality of Life measures (EORTC) |
| Patient reported outcomes measures (LARS) | Pretreatment and at 1 and 3 years | Patient reported outcome measure by LARS (low anterior resection syndrome) scores 1-5 |
Countries
Denmark
Outcome results
None listed