Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT03254420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2017-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
Sponsor:
Organization:
Raw JSON
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0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'investigations', 'notes': 'grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'musculoskeletal and connective tissue disorders', 'notes': 'grade 1 and 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'nervous system disorder', 'notes': 'grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'basela cell carcinoma grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'vascular stent stenosis grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'peripheral artery stenosis grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'malignant melanoma grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'colon cancer metastatic grade 5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'cerebral hematoma grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, 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Evidence-based radiation oncology: definitive, adjuvant and salvage radiotherapy for non-metastatic prostate cancer. Radiother Oncol. 2007 Aug;84(2):197-215. doi: 10.1016/j.radonc.2007.04.013. Epub 2007 May 29.'}, {'pmid': '24018567', 'type': 'BACKGROUND', 'citation': 'Zaorsky NG, Harrison AS, Trabulsi EJ, Gomella LG, Showalter TN, Hurwitz MD, Dicker AP, Den RB. Evolution of advanced technologies in prostate cancer radiotherapy. Nat Rev Urol. 2013 Oct;10(10):565-79. doi: 10.1038/nrurol.2013.185. Epub 2013 Sep 10.'}, {'pmid': '22001105', 'type': 'BACKGROUND', 'citation': 'Budaus L, Bolla M, Bossi A, Cozzarini C, Crook J, Widmark A, Wiegel T. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur Urol. 2012 Jan;61(1):112-27. doi: 10.1016/j.eururo.2011.09.027. Epub 2011 Oct 6.'}, {'pmid': '22892261', 'type': 'BACKGROUND', 'citation': 'Ohri N, Dicker AP, Showalter TN. Late toxicity rates following definitive radiotherapy for prostate cancer. Can J Urol. 2012 Aug;19(4):6373-80.'}, {'pmid': '20921463', 'type': 'BACKGROUND', 'citation': 'Pardo Y, Guedea F, Aguilo F, Fernandez P, Macias V, Marino A, Hervas A, Herruzo I, Ortiz MJ, Ponce de Leon J, Craven-Bratle J, Suarez JF, Boladeras A, Pont A, Ayala A, Sancho G, Martinez E, Alonso J, Ferrer M. Quality-of-life impact of primary treatments for localized prostate cancer in patients without hormonal treatment. J Clin Oncol. 2010 Nov 1;28(31):4687-96. doi: 10.1200/JCO.2009.25.3245. Epub 2010 Oct 4.'}, {'pmid': '20797890', 'type': 'BACKGROUND', 'citation': 'de Crevoisier R, Fiorino C, Dubray B. [Dosimetric factors predictive of late toxicity in prostate cancer radiotherapy]. Cancer Radiother. 2010 Oct;14(6-7):460-8. doi: 10.1016/j.canrad.2010.07.225. Epub 2010 Aug 24. French.'}, {'pmid': '19544543', 'type': 'BACKGROUND', 'citation': 'Valdagni R, Rancati T, Fiorino C. 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Arch Public Health. 2014 Nov 10;72(1):39. doi: 10.1186/2049-3258-72-39. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.\n\nThe aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.', 'detailedDescription': 'Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference treatments for localized prostate cancer. Prostate was initially thought to be a non-moving target, but the newest reports have raised the contrary as evidence. Image-guided radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which enables to take into account interfractional prostate motion before treatment.\n\nThe Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.\n\nAs Planned Target Volume (PTV) margins integrate set-up margins and the management of organ motion, margin reduction can reasonably be considered in case of target motion management improvement.\n\nTo date, no prospective randomized clinical data is available using this technique for the treatment of low- or intermediate-risk prostate cancer patients with modern standard fractionation radiotherapy and image guidance.\n\nThe aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Localized prostate cancer, histologically proven.\n* No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral lymph node dissection is not mandatory if lymph node involvement risk is low according to the Partin tables).\n* Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2 and Gleason \\< 8 and PSA \\< 20 ng/ml) (appendix 3).\n* No grade \\> 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03 scale.\n* Performance status ECOG ≤ 1.\n* No hip prosthesis or metallic vascular graft near the prostate.\n* No endopenian stent.\n* No pace maker, implanted defibrillator or neurostimulator.\n* No allergy to local anesthetics.\n* No irreversible anticoagulation or antiplatelet treatment for the implantation period.\n* Pelvic and abdominal anatomy compatible with the use of the Calypso® system (predictive detector to fiducials distance less than 19 cm, evaluated on planning CT-scan) (distance from skin surface to prostate center less than 17 cm).\n* Patient aged ≥ 18 and less than 80 years old.\n* Dated and signed written informed consent available.\n* Patients must be affiliated to a French Social Security System.\n\nExclusion Criteria:\n\n* Indication of pelvic nodes irradiation.\n* Prior pelvic irradiation.\n* Biopsy-proven seminal vesicle invasion.\n* Prior bilateral orchiectomy.\n* Prior radical prostatectomy.\n* Other malignancy except adequately-treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease-free for at least 5 years.\n* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n* Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary embolism, etc.).\n* Known VIH positive patients (no specific test needed).\n* Known homozygote ATM Mutation (Ataxia telengiectasia)."}, 'identificationModule': {'nctId': 'NCT03254420', 'acronym': 'RCMIGI', 'briefTitle': 'Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)', 'orgStudyIdInfo': {'id': 'ICM-URC2015/33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Image-guided radiation therapy (IGRT) with standard margins', 'description': 'moderate hypofractionation during 4 weeks', 'interventionNames': ['Radiation: moderate hypofractionation Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Calypso tracking system with margin reduction', 'description': 'moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before', 'interventionNames': ['Device: Calypso beacon implant', 'Radiation: moderate hypofractionation Radiotherapy']}], 'interventions': [{'name': 'Calypso beacon implant', 'type': 'DEVICE', 'description': 'Calypso beacon implant before radiotherapy', 'armGroupLabels': ['Calypso tracking system with margin reduction']}, {'name': 'moderate hypofractionation Radiotherapy', 'type': 'RADIATION', 'description': 'moderate hypofractionation Radiotherapy', 'armGroupLabels': ['Calypso tracking system with margin reduction', 'Image-guided radiation therapy (IGRT) with standard margins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut regional du Cancer - Val d Aurelle', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Riou Olivier', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut régional du Cancer de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}