Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

Study Overview
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Brief 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.

Detailed Description
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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.

Official Title
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Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study

Conditions
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Gonarthrosis, Coxarthrosis

Intervention / Treatment
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* Radiation: Low dose radiotherapy A
* Radiation: Low dose radiotherapy B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: 3 Gy (repeated at 8 weeks if necessary. New ramdomization to 3 Gy or 6 Gy) Arm 2: 6 Gy (repeated at 8 weeks if necessry)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy 3 Gy<br>Patiens will receive low dose gonarthrosis or coxarthrosis radiotherapy (0.5 Gy in 6 fractions alternating days). Evaluation of pain releave and quality of live in 8-12 weeks If no effect the patient will be randomized to 3 or 6 Gy again | Radiation: Low dose radiotherapy A<br>* Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is randomized to 3 or 6 Gy again<br>|
| Active Comparator: Radiotherapy 6 Gy<br>Patiens will receive low dose gonarthrosis or coxarthrosis radiotherapy (1 Gy in 6 fractions alternating days). Evaluation of pain releave and quality of live in 8-12 weeks If no effect the patient will be treated with 6 Gy again | Radiation: Low dose radiotherapy B<br>* Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is treated with 6 Gy again<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Dose Radiotherapy, Anti-inflammatory effects, Pain release, Quality of Life