MedTrace Logo

Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial

NCT06104410 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2023-10-31

No results posted yet for this study

Summary

About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the general population. Heel spur represents important socioeconomic as well as health care issue. Radiotherapy by orthovoltage X-ray belongs to standard conservative treatment methods with proven antiinflammatory effect. Nevertheless, with increasing incidence of cancer, it may be assumed that availability of radiotherapy service for heel spur patients will be further limited including limitations related to potential pandemic or other emergency situation. This represents upcoming unmet clinical need, where alternative approaches with dramatically abbreviated fractionation schedules are needed in order to keep availability as well as effectivity of heel spur (and other non-malignant disorders) radiotherapy.

The aim to presented single institutional prospective randomized open-lable clinical trial is to evaluate low dose radiotherapy delivered in single fraction manner in the treatment of heel spur syndrome.

The project aims to design a randomized trial that compared fractionated and single fraction radiotherapy (non-inferiority). Patients will be randomized into 6 groups according to the total dose, total of 966 patients will be enrolled. The primary objective is to compare Calcaneodynia sum score at 3 months after radiotherapy between fractionated vs. single fraction radiotherapy.

Conditions

  • Heel Spur

Interventions

RADIATION

Standard fractioned dose

Total dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly.

RADIATION

Experimental single dose

Total dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction.

Sponsors & Collaborators

  • Masaryk Memorial Cancer Institute

    lead OTHER

Principal Investigators

  • Pavel Slampa, prof. MD · Masaryk Memorial Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06104410 on ClinicalTrials.gov