Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis (RAGOCO)

Fundacion GenesisCare

Status: Unknown

Conditions: Gonarthrosis; Coxarthrosis

Treatments: Radiation: Low dose radiotherapy A; Radiation: Low dose radiotherapy B

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04424628

GEN-RAD-2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 338 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

338 participants in 2 patient groups

Radiotherapy 3 Gy

Active Comparator group

Description:

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

Treatment:

Radiation: Low dose radiotherapy A

Radiotherapy 6 Gy

Active Comparator group

Description:

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

Treatment:

Radiation: Low dose radiotherapy B