Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

NCT ID: NCT05385250

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2026-03-01

Brief Summary

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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.

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.

Conditions

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Anal Cancer Radiotherapy Side Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A phase II prospective observational clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone sparring radiotherapy

Observational arm of bone-sparing radiotherapy

Group Type OTHER

Bone sparring radiotherapy

Intervention Type OTHER

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

Interventions

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Bone sparring radiotherapy

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role collaborator

Karen-Lise Garm Spindler

OTHER

Sponsor Role lead

Responsible Party

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Karen-Lise Garm Spindler

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karen-Lise G Spindler, DMSc, PhD

Role: STUDY_CHAIR

Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DACG-II

Identifier Type: -

Identifier Source: org_study_id

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