Gonarthrosis Clinical Trial
— RAGOCOOfficial title:
Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study
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.
Status | Recruiting |
Enrollment | 338 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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. 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 |
Country | Name | City | State |
---|---|---|---|
Spain | GenesisCare Malaga | Malaga |
Lead Sponsor | Collaborator |
---|---|
Fundacion GenesisCare | Elekta |
Spain,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain control at 8-12 weeks and every 6 months | To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with VAS (Visual Analogue Scale). The patient scores his painfrom 0 (no hurt) to 10 (hurts worst). It is better a low score. | At 8-12 weeks, 6 months, 12 months, 18 months and 24 months | |
Primary | Quality of Life at 8-12 weeks and every 6 months | To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with WOMAC scale (Western Ontario MacMaster Questionnaire). This questionnaire has 24 questions about pain, joint stiffness and joint function. It is better a low score. | At 8-12 weeks, 6 months, 12 months, 18 months and 24 months | |
Secondary | Skin toxicity at 8-12 weeks. | Skin toxicity will be assessed and rated acording to the RTOG scale (0= no change over baseline; 1: Follicular, faint or dull erythema epilation, dry desquamation, decreased sweating; 2: Tender or bright erythema, patchy moist desquamation, moderate oedema; 3: Confluent, moist desquamation other tan skin folds, pitting oedema; 4: Ulceration haemorrhege, necrosis. | At 8-12 weeks. |
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