Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis (RAGOCO)
Primary Purpose
Gonarthrosis, Coxarthrosis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low dose radiotherapy A
Low dose radiotherapy B
Sponsored by
About this trial
This is an interventional supportive care trial for Gonarthrosis focused on measuring Low Dose Radiotherapy, Anti-inflammatory effects, Pain release, Quality of Life
Eligibility Criteria
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
Sites / Locations
- GenesisCare MalagaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Radiotherapy 3 Gy
Radiotherapy 6 Gy
Arm 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
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04424628
First Posted
June 1, 2020
Last Updated
June 19, 2020
Sponsor
Fundacion GenesisCare
Collaborators
Elekta Limited
1. Study Identification
Unique Protocol Identification Number
NCT04424628
Brief Title
Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis
Acronym
RAGOCO
Official Title
Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion GenesisCare
Collaborators
Elekta Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis, Coxarthrosis
Keywords
Low Dose Radiotherapy, Anti-inflammatory effects, Pain release, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Patients label
Allocation
Randomized
Enrollment
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy 3 Gy
Arm Type
Active Comparator
Arm 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
Arm Title
Radiotherapy 6 Gy
Arm Type
Active Comparator
Arm 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
Intervention Type
Radiation
Intervention Name(s)
Low dose radiotherapy A
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Low dose radiotherapy B
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain control at 8-12 weeks and every 6 months
Description
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
Title
Quality of Life at 8-12 weeks and every 6 months
Description
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 Outcome Measure Information:
Title
Skin toxicity at 8-12 weeks.
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Rivas Sanchez, MD
Phone
+34951569589
Email
daniel.rivas@genesiscare.es
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Hernaz, MD
Phone
+34915644383
Email
raul.hernanz@genesiscare.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rivas Sanchez, MD
Organizational Affiliation
Fundacion GenesisCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
GenesisCare Malaga
City
Malaga
ZIP/Postal Code
29018
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rivas Sanchez, MD
Phone
+34951569589
Email
daniel.rivas@genesiscare.es
First Name & Middle Initial & Last Name & Degree
Raul Hernanz, MD
Phone
+34915644383
Email
raul.hernanz@genesiscare.es
First Name & Middle Initial & Last Name & Degree
Daniel Rivas Sanchez, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The overall results of any research conducted Will be available on study data publication
Supportin information:
Study protocol Informed Consent Form (ICF)
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Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis
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