Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-04 @ 4:54 AM
Study NCT ID:
NCT03841435
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy for Recurrent DIPG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080443', 'term': 'Diffuse Intrinsic Pontine Glioma'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020295', 'term': 'Brain Stem Neoplasms'}, {'id': 'D015192', 'term': 'Infratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}], 'ancestors': [{'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Radiation Toxicity', 'timeFrame': 'Through Study Completion, an average of 1 year', 'description': 'RTOG common toxicity criteria grade 0-5'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life score', 'timeFrame': 'Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT', 'description': 'Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0'}, {'measure': 'Radiographic Response', 'timeFrame': '1 month', 'description': 'Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Through Study Completion, an average of 1 year', 'description': 'Time to clinical, symptomatic or radiographic evidence of disease progression'}, {'measure': 'Overall Survival', 'timeFrame': 'Through Study Completion, an average of 1 year', 'description': 'Time to patient death'}, {'measure': 'Steroid Requirement', 'timeFrame': 'Through Study Completion, an average of 1 year', 'description': 'Use of steroids post-RT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Diffuse Intrinsic Pontine Glioma']}, 'referencesModule': {'references': [{'pmid': '24137015', 'type': 'BACKGROUND', 'citation': 'Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, Stroup NE, Kruchko C, Barnholtz-Sloan JS. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013 Nov;15 Suppl 2(Suppl 2):ii1-56. doi: 10.1093/neuonc/not151. No abstract available.'}, {'pmid': '26557503', 'type': 'BACKGROUND', 'citation': 'Vanan MI, Eisenstat DD. DIPG in Children - What Can We Learn from the Past? Front Oncol. 2015 Oct 21;5:237. doi: 10.3389/fonc.2015.00237. eCollection 2015.'}, {'pmid': '19638636', 'type': 'BACKGROUND', 'citation': 'Fangusaro J. Pediatric high-grade gliomas and diffuse intrinsic pontine gliomas. J Child Neurol. 2009 Nov;24(11):1409-17. doi: 10.1177/0883073809338960. Epub 2009 Jul 28.'}, {'pmid': '21297433', 'type': 'BACKGROUND', 'citation': 'Fontanilla HP, Pinnix CC, Ketonen LM, Woo SY, Vats TS, Rytting ME, Wolff JE, Mahajan A. Palliative reirradiation for progressive diffuse intrinsic pontine glioma. Am J Clin Oncol. 2012 Feb;35(1):51-7. doi: 10.1097/COC.0b013e318201a2b7.'}, {'pmid': '18406885', 'type': 'BACKGROUND', 'citation': 'Merchant TE, Boop FA, Kun LE, Sanford RA. A retrospective study of surgery and reirradiation for recurrent ependymoma. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):87-97. doi: 10.1016/j.ijrobp.2007.09.037.'}, {'pmid': '19260098', 'type': 'BACKGROUND', 'citation': 'Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.'}, {'pmid': '22245198', 'type': 'BACKGROUND', 'citation': 'Bouffet E, Hawkins CE, Ballourah W, Taylor MD, Bartels UK, Schoenhoff N, Tsangaris E, Huang A, Kulkarni A, Mabbot DJ, Laperriere N, Tabori U. Survival benefit for pediatric patients with recurrent ependymoma treated with reirradiation. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):1541-8. doi: 10.1016/j.ijrobp.2011.10.039. Epub 2012 Jan 13.'}, {'pmid': '23972764', 'type': 'BACKGROUND', 'citation': 'Iqbal MS, Lewis J. An overview of the management of adult ependymomas with emphasis on relapsed disease. Clin Oncol (R Coll Radiol). 2013 Dec;25(12):726-33. doi: 10.1016/j.clon.2013.07.009. Epub 2013 Aug 20.'}, {'pmid': '18037587', 'type': 'BACKGROUND', 'citation': 'Mayer R, Sminia P. Reirradiation tolerance of the human brain. Int J Radiat Oncol Biol Phys. 2008 Apr 1;70(5):1350-60. doi: 10.1016/j.ijrobp.2007.08.015. Epub 2007 Nov 26.'}, {'pmid': '24696052', 'type': 'BACKGROUND', 'citation': 'Massimino M, Biassoni V, Miceli R, Schiavello E, Warmuth-Metz M, Modena P, Casanova M, Pecori E, Giangaspero F, Antonelli M, Buttarelli FR, Potepan P, Pollo B, Nunziata R, Spreafico F, Podda M, Anichini A, Clerici CA, Sardi I, De Cecco L, Bode U, Bach F, Gandola L. Results of nimotuzumab and vinorelbine, radiation and re-irradiation for diffuse pontine glioma in childhood. J Neurooncol. 2014 Jun;118(2):305-312. doi: 10.1007/s11060-014-1428-z. Epub 2014 Apr 3.'}, {'type': 'BACKGROUND', 'citation': 'Lassaletta A, Bartels U, Strother D, et al. Hg-57re-irradiation in patients with diffuse intrinsic pontine gliomas, an update on the canadian experience. Neuro-Oncology 2016;18:iii60-iii61.'}, {'pmid': '28274399', 'type': 'BACKGROUND', 'citation': 'Freese C, Takiar V, Fouladi M, DeWire M, Breneman J, Pater L. Radiation and subsequent reirradiation outcomes in the treatment of diffuse intrinsic pontine glioma and a systematic review of the reirradiation literature. Pract Radiat Oncol. 2017 Mar-Apr;7(2):86-92. doi: 10.1016/j.prro.2016.11.005. Epub 2016 Nov 23.'}, {'pmid': '24078173', 'type': 'BACKGROUND', 'citation': 'Hoffman LM, Plimpton SR, Foreman NK, Stence NV, Hankinson TC, Handler MH, Hemenway MS, Vibhakar R, Liu AK. Fractionated stereotactic radiosurgery for recurrent ependymoma in children. J Neurooncol. 2014 Jan;116(1):107-11. doi: 10.1007/s11060-013-1259-3.'}, {'pmid': '20171516', 'type': 'BACKGROUND', 'citation': 'Mayo C, Yorke E, Merchant TE. Radiation associated brainstem injury. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S36-41. doi: 10.1016/j.ijrobp.2009.08.078.'}, {'pmid': '8407392', 'type': 'BACKGROUND', 'citation': 'Freeman CR, Krischer JP, Sanford RA, Cohen ME, Burger PC, del Carpio R, Halperin EC, Munoz L, Friedman HS, Kun LE. Final results of a study of escalating doses of hyperfractionated radiotherapy in brain stem tumors in children: a Pediatric Oncology Group study. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):197-206. doi: 10.1016/0360-3016(93)90228-n.'}, {'pmid': '8339232', 'type': 'BACKGROUND', 'citation': 'Packer RJ, Boyett JM, Zimmerman RA, Rorke LB, Kaplan AM, Albright AL, Selch MT, Finlay JL, Hammond GD, Wara WM. Hyperfractionated radiation therapy (72 Gy) for children with brain stem gliomas. A Childrens Cancer Group Phase I/II Trial. Cancer. 1993 Aug 15;72(4):1414-21. doi: 10.1002/1097-0142(19930815)72:43.0.co;2-c.'}, {'pmid': '8082086', 'type': 'BACKGROUND', 'citation': 'Packer RJ, Boyett JM, Zimmerman RA, Albright AL, Kaplan AM, Rorke LB, Selch MT, Cherlow JM, Finlay JL, Wara WM. Outcome of children with brain stem gliomas after treatment with 7800 cGy of hyperfractionated radiotherapy. A Childrens Cancer Group Phase I/II Trial. Cancer. 1994 Sep 15;74(6):1827-34. doi: 10.1002/1097-0142(19940915)74:63.0.co;2-q.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be ≤30 years of age\n2. Patients must have a diagnosis of progressive DIPG.\n3. Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy.\n4. The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition.\n5. Steroids dosage must be unchanged for 5 days.\n6. No Bevacizumab within 21 days (Half-life 11 days \\~)\n\nExclusion Criteria:\n\n1. Patients with incomplete medical records\n2. Patients with prior history of reirradiation for DIPG\n3. Life expectancy \\< or equal to 1 month\n4. Pregnant women\n5. Age \\>30\n6. Prisoners\n7. Concurrent systemic therapy at the time of reirradiation\n8. Physically or mentally incapable of signing the consent form of their own volition\n9. \\< 6 mos time interval between completion of initial RT to start of reRT.'}, 'identificationModule': {'nctId': 'NCT03841435', 'briefTitle': 'Hypofractionated Radiotherapy for Recurrent DIPG', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma', 'orgStudyIdInfo': {'id': '2017-2183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated Radiotherapy', 'description': '15 Gy given in 3 fractions over 2 weeks', 'interventionNames': ['Radiation: Hypofractionated Radiotherapy']}], 'interventions': [{'name': 'Hypofractionated Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.', 'armGroupLabels': ['Hypofractionated Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Luke E Pater, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will be kept confidential and will not be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiation Oncology, Mediacal Director, West Chester Hospital Radiotherapy', 'investigatorFullName': 'Luke Pater', 'investigatorAffiliation': 'University of Cincinnati'}}}}