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GonarthrosisRAGOCONCT04424628

Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

A study testing Low dose radiotherapy A and Low dose radiotherapy B in people with Gonarthrosis and Coxarthrosis, run by Fundacion GenesisCare at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Gonarthrosis, Coxarthrosis
What is being tested?
Low dose radiotherapy A and Low dose radiotherapy B
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
1 siteSpain
Study dates
1 May 2019to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Daniel Rivas Sanchez, MD contact

+34951569589

daniel.rivas@genesiscare.es

Raul Hernaz, MD contact

+34915644383

raul.hernanz@genesiscare.es

Spain1 site, 1 recruiting

  • GenesisCare Malaga

    Málaga, 29018

    Daniel Rivas Sanchez, MD, +34951569589, daniel.rivas@genesiscare.es

    Raul Hernanz, MD, +34915644383, raul.hernanz@genesiscare.es

    Recruiting

Other trials in Spain

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Low dose radiotherapy A, Low dose radiotherapy B
Keywords
Low Dose Radiotherapy, Anti-inflammatory effects, Pain release, Quality of Life
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04424628
Study groupRoleWhat they receive
Radiotherapy 3 GyActive comparatorPatiens 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
Receives: Radiation: Low dose radiotherapy A
Radiotherapy 6 GyActive comparatorPatiens 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
Receives: Radiation: Low dose radiotherapy B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (1)

  1. 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.

    Measured: At 8-12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start1 May 2019
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
338 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04424628
Sponsor's protocol ID
GEN-RAD-2019-01
Acronym
RAGOCO
Status last verified
Jun 2020
First submitted
1 Jun 2020
Last updated
22 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The overall results of any research conducted Will be available on study data publication Supportin information: Study protocol Informed Consent Form (ICF)

Publications

  • Micke O, Seegenschmiedt MH; German Working Group on Radiotherapy in Germany. Consensus guidelines for radiation therapy of benign diseases: a multicenter approach in Germany. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):496-513. doi: 10.1016/s0360-3016(01)01814-4.

    PubMed 11872298

  • Montero Luis A, Hernanz de Lucas R, Hervas Moron A, Fernandez Lizarbe E, Sancho Garcia S, Vallejo Ocana C, Polo Rubio A, Ramos Aguerri A. Radiation therapy for the treatment of benign vascular, skeletal and soft tissue diseases. Clin Transl Oncol. 2008 Jun;10(6):334-46. doi: 10.1007/s12094-008-0209-6.

    PubMed 18558580

  • Reichl B, Block A, Schafer U, Bert C, Muller R, Jung H, Rodel F; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO practical guidelines for radiotherapy of non-malignant disorders: Part I: physical principles, radiobiological mechanisms, and radiogenic risk. Strahlenther Onkol. 2015 Sep;191(9):701-9. doi: 10.1007/s00066-015-0865-8. Epub 2015 Jun 28.

    PubMed 26117368

  • Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med. 2009 Dec 14;169(22):2078-86. doi: 10.1001/archinternmed.2009.427.

    PubMed 20008690

  • Jansen JT, Broerse JJ, Zoetelief J, Klein C, Seegenschmiedt HM. Estimation of the carcinogenic risk of radiotherapy of benign diseases from shoulder to heel. Radiother Oncol. 2005 Sep;76(3):270-7. doi: 10.1016/j.radonc.2005.06.034.

    PubMed 16157402

  • Minten MJM, Leseman-Hoogenboom MM, Kloppenburg M, Kortekaas MC, Leer JW, Poortmans PMP, van den Hoogen FHJ, den Broeder AA, van den Ende CHM. Lack of beneficial effects of low-dose radiation therapy on hand osteoarthritis symptoms and inflammation: a randomised, blinded, sham-controlled trial. Osteoarthritis Cartilage. 2018 Oct;26(10):1283-1290. doi: 10.1016/j.joca.2018.06.010. Epub 2018 Jul 7.

    PubMed 30231990

  • Arenas M, Sabater S, Hernandez V, Rovirosa A, Lara PC, Biete A, Panes J. Anti-inflammatory effects of low-dose radiotherapy. Indications, dose, and radiobiological mechanisms involved. Strahlenther Onkol. 2012 Nov;188(11):975-81. doi: 10.1007/s00066-012-0170-8. Epub 2012 Aug 22.

    PubMed 22907572

  • Kern PM, Keilholz L, Forster C, Hallmann R, Herrmann M, Seegenschmiedt MH. Low-dose radiotherapy selectively reduces adhesion of peripheral blood mononuclear cells to endothelium in vitro. Radiother Oncol. 2000 Mar;54(3):273-82. doi: 10.1016/s0167-8140(00)00141-9.

    PubMed 10738086

  • Hildebrandt G, Seed MP, Freemantle CN, Alam CA, Colville-Nash PR, Trott KR. Mechanisms of the anti-inflammatory activity of low-dose radiation therapy. Int J Radiat Biol. 1998 Sep;74(3):367-78. doi: 10.1080/095530098141500.

    PubMed 9737539

  • Leer JW, van Houtte P, Davelaar J. Indications and treatment schedules for irradiation of benign diseases: a survey. Radiother Oncol. 1998 Sep;48(3):249-57. doi: 10.1016/s0167-8140(98)00051-6.

    PubMed 9925244

  • Ott OJ, Niewald M, Weitmann HD, Jacob I, Adamietz IA, Schaefer U, Keilholz L, Heyd R, Muecke R; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO guidelines for the radiotherapy of non-malignant disorders. Part II: Painful degenerative skeletal disorders. Strahlenther Onkol. 2015 Jan;191(1):1-6. doi: 10.1007/s00066-014-0757-3. Epub 2014 Sep 20.

    PubMed 25238992

  • Seegenschmiedt MH, Katalinic A, Makoski H, Haase W, Gademann G, Hassenstein E. Radiation therapy for benign diseases: patterns of care study in Germany. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):195-202. doi: 10.1016/s0360-3016(99)00537-4.

    PubMed 10758324

  • Leer JW, van Houtte P, Seegenschmiedt H. Radiotherapy of non-malignant disorders: where do we stand? Radiother Oncol. 2007 May;83(2):175-7. doi: 10.1016/j.radonc.2007.04.008. Epub 2007 May 8.

    PubMed 17490769

  • Seegenschmiedt MH. New future for radiation therapy of non-malignant diseases? Radiother Oncol. 2005 Jan;74(1):1-2. doi: 10.1016/j.radonc.2005.01.001. No abstract available.

    PubMed 15683660

  • Micke O, Ugrak E, Bartmann S, Adamietz IA, Schaefer U, Bueker R, Kisters K, Heinrich Seegenschmiedt M, Fakhrian K, Muecke R. Radiotherapy for calcaneodynia, achillodynia, painful gonarthrosis, bursitis trochanterica, and painful shoulder syndrome - Early and late results of a prospective clinical quality assessment. Radiat Oncol. 2018 Apr 19;13(1):71. doi: 10.1186/s13014-018-1025-y.

    PubMed 29673383

Questions about this trial

What is this clinical trial studying?

A study testing Low dose radiotherapy A and Low dose radiotherapy B in people with Gonarthrosis and Coxarthrosis, run by Fundacion GenesisCare at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel Rivas Sanchez, MD (+34951569589, daniel.rivas@genesiscare.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04424628, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.

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