Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Pain control at 8-12 weeks and every 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Patients label
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Radiotherapy 3 Gy
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
干预措施: Low dose radiotherapy A (Radiation)
Radiotherapy 6 Gy
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
干预措施: Low dose radiotherapy B (Radiation)
结局指标
主要结局
Pain control at 8-12 weeks and every 6 months
时间窗: At 8-12 weeks, 6 months, 12 months, 18 months and 24 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.
Quality of Life at 8-12 weeks and every 6 months
时间窗: At 8-12 weeks, 6 months, 12 months, 18 months and 24 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.
次要结局
- Skin toxicity at 8-12 weeks.(At 8-12 weeks.)