Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

Last updated: June 19, 2020
Sponsor: Fundacion GenesisCare
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT04424628
GEN-RAD-2019-01
  • Ages > 50
  • All Genders

Study Summary

This is a non-inferiority study in which the investigators compare two low-dose radiotherapy schemes, which are recommended from DEGRO Clinical Practice Guidelines (3 Gy vs 6 Gy) for the treatment of osteoarthritis and other osteodegenerative disorders.

A first randomization will be carried out among the patients included in the study:

  • Patients in arm A will be treated at 3 Gy (0.5 Gy/fraction, 3 fractions/week), and patients in arm B will be treated at 6 Gy (1 Gy/fraction, 3 fractions/week).

  • Patients should not know the arm to which they have been randomized.

  • Once the treatment is finished, patients will be assessed at 8 weeks. If pain does not improve, a re-irradiation will be performed. If the patients were treated with 3 Gy a new randomization will be performed (3 vs 6 Gy again). If the patiens were treated with 6 Gy they will be re-irradiated with 6 Gy again.

The investigators will analyze the results obtained depending on the dose received and depending on the location of the treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >50 years

  • Gonarthrosis or/and Coxarthrosis diagnose

  • At least 1 year of evolution

  • Non response to drug or surgery treatments

  • Risk of colateral side effects due to the comorbidity of the patient with conventionaltreatments.

Exclusion

Exclusion Criteria:

  • Previous high dose radiotherapy in the same location

  • Conective tissue disease (LUPUS, reumathoid artritis, esclerodermia, Sd. Raynaud, Sd.Sjögren, polymiositis)

  • Inherited Hipersesitivity Sindromes (ataxia-telangiectasia, Fanconi's anaemya, Sd.Nijmegen, Sd. Gorlyn, Sd. Cockayne, Sd. Down, Sd. Gardner, Sd. Usher)

  • No follow up possibility

  • Other study inclusion

Study Design

Total Participants: 338
Study Start date:
May 01, 2019
Estimated Completion Date:
April 30, 2023

Study Description

Painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. DEGRO guidelines recommend a dose between 3 and 6 Gy at 0'5 Gy/fraction or 1 Gy/fraction respectively. The investigators want to verify that both treatments (3 and 6 Gy) are similar to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are no differences between both treatments, therefore, 3 Gy is not less than 6 Gy.

In this context, a prospective multicenter study is proposed. The study will include 338 patients to assess the efficacy of low dose irradiation (3 vs 6 Gy) in gonarthrosis and coxarthrosis.

Connect with a study center

  • GenesisCare Malaga

    Malaga, 29018
    Spain

    Active - Recruiting

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