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

June 19, 2020 updated by: Fundacion GenesisCare

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Radiation: Low dose radiotherapy A
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
Active Comparator: 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
Radiation: Low dose radiotherapy B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain control at 8-12 weeks and every 6 months
Time Frame: 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.
At 8-12 weeks, 6 months, 12 months, 18 months and 24 months
Quality of Life at 8-12 weeks and every 6 months
Time Frame: 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.
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.
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion GenesisCare

Collaborators

Elekta Limited

Investigators

  • Principal Investigator: Daniel Rivas Sanchez, MD, Fundacion GenesisCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-RAD-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The overall results of any research conducted Will be available on study data publication

Supportin information:

Study protocol Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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