Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

STATUS

Recruiting
participants needed

338
sponsor

Fundacion GenesisCare

Updated on 19 February 2024

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osteoarthritis

Summary

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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.

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.

Details

Condition	Osteoarthritis of hip, Osteoarthritis, Osteoarthritis, Gonarthrosis
Age	50years - 100years
Treatment	Low dose radiotherapy A, Low dose radiotherapy B
Clinical Study Identifier	NCT04424628
Sponsor	Fundacion GenesisCare
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 conventional treatments
Exclusion Criteria
	Previous high dose radiotherapy in the same location
	Conective tissue disease (LUPUS, reumathoid artritis, esclerodermia, Sd. Raynaud, Sd. Sjgren, 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

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Daniel Rivas Sanchez, MD

Primary Contact

GenesisCare Malaga

Spain

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Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis