RAGOCO: Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis
Study Details
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:
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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).
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Patients should not know the arm to which they have been randomized.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pain control at 8-12 weeks and every 6 months [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 [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.
Secondary Outcome Measures
- Skin toxicity at 8-12 weeks. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >50 years
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Gonarthrosis or/and Coxarthrosis diagnose
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At least 1 year of evolution
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Non response to drug or surgery treatments
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Risk of colateral side effects due to the comorbidity of the patient with conventional treatments.
Exclusion Criteria:
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Previous high dose radiotherapy in the same location
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Conective tissue disease (LUPUS, reumathoid artritis, esclerodermia, Sd. Raynaud, Sd. Sjögren, polymiositis)
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Inherited Hipersesitivity Sindromes (ataxia-telangiectasia, Fanconi's anaemya, Sd. Nijmegen, Sd. Gorlyn, Sd. Cockayne, Sd. Down, Sd. Gardner, Sd. Usher)
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No follow up possibility
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Other study inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GenesisCare Malaga | Malaga | Spain | 29018 |
Sponsors and Collaborators
- Fundacion GenesisCare
- Elekta Limited
Investigators
- Principal Investigator: Daniel Rivas Sanchez, MD, Fundacion GenesisCare
Study Documents (Full-Text)
None provided.More Information
Publications
- Arenas M, Sabater S, Hernández V, Rovirosa A, Lara PC, Biete A, Panés 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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.
- Montero Luis A, Hernanz de Lucas R, Hervás Morón A, Fernández Lizarbe E, Sancho García S, Vallejo Ocaña 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. Review.
- Reichl B, Block A, Schäfer U, Bert C, Müller R, Jung H, Rödel 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.
- Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de González 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.
- GEN-RAD-2019-01