Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

N/AActive Not RecruitingNCT05385250

Karen-Lise Garm Spindler100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Anal Cancer Radiotherapy Side Effect

Interventions

Bone sparring radiotherapyOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Rate of PIFs

Rate of pelvic insufficience fractures (PIF) on MRI

Time frame: 1 year

Secondary Outcomes

Rate of symptomatic PIFs

Rate of symptomatic Pelvic insufficiency fractures (PIF)

Time frame: 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

Time frame: after 1 and 3 years

Predictive and prognostic biomarkers

Prognostic value of levels of circulating DNA (copies per ML) in blood samples

Time frame: 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

Time frame: 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

Time frame: Pretreatment and after 1 and 3 years

Quality of Life measures (EORTC)

Time frame: Pretreatment and after 1 and 3 years

Data from ClinicalTrials.gov

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