Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

Fundacion GenesisCare338 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

338

Interventions

Low dose radiotherapy ARADIATION

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

Low dose radiotherapy BRADIATION

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At 8-12 weeks, 6 months, 12 months, 18 months and 24 months

Secondary Outcomes

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.

Time frame: At 8-12 weeks.