Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04783818
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-05', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reconstruction failure', 'timeFrame': '2 years', 'description': 'Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)'}], 'secondaryOutcomes': [{'measure': 'Reconstruction Complications', 'timeFrame': '2 years', 'description': 'Rate of capsular contracture and rate of need for reintervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mammaplasty', 'Radiotherapy; Complications', 'Breast Implant; Complications', 'Transplant Failure']}, 'referencesModule': {'references': [{'pmid': '11000574', 'type': 'BACKGROUND', 'citation': 'Al-Ghazal SK, Fallowfield L, Blamey RW. Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction. Eur J Cancer. 2000 Oct;36(15):1938-43. doi: 10.1016/s0959-8049(00)00197-0.'}, {'pmid': '18843123', 'type': 'BACKGROUND', 'citation': 'Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.'}, {'pmid': '27659727', 'type': 'BACKGROUND', 'citation': 'Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY, Hudis CA, Hwang ES, Kirshner JJ, Morrow M, Salerno KE, Sledge GW Jr, Solin LJ, Spears PA, Whelan TJ, Somerfield MR, Edge SB. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e219-e234. doi: 10.1016/j.prro.2016.08.009. Epub 2016 Sep 19.'}, {'pmid': '18535851', 'type': 'BACKGROUND', 'citation': 'Yanko-Arzi R, Cohen MJ, Braunstein R, Kaliner E, Neuman R, Brezis M. Breast reconstruction: complication rate and tissue expander type. Aesthetic Plast Surg. 2009 Jul;33(4):489-96. doi: 10.1007/s00266-008-9192-0. Epub 2008 Jun 6.'}, {'pmid': '20855758', 'type': 'BACKGROUND', 'citation': 'Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170.'}, {'pmid': '20853034', 'type': 'BACKGROUND', 'citation': 'Berry T, Brooks S, Sydow N, Djohan R, Nutter B, Lyons J, Dietz J. Complication rates of radiation on tissue expander and autologous tissue breast reconstruction. Ann Surg Oncol. 2010 Oct;17 Suppl 3:202-10. doi: 10.1245/s10434-010-1261-3. Epub 2010 Sep 19.'}, {'pmid': '18626350', 'type': 'BACKGROUND', 'citation': 'Chang DW, Barnea Y, Robb GL. Effects of an autologous flap combined with an implant for breast reconstruction: an evaluation of 1000 consecutive reconstructions of previously irradiated breasts. Plast Reconstr Surg. 2008 Aug;122(2):356-362. doi: 10.1097/PRS.0b013e31817d6303.'}, {'pmid': '16462313', 'type': 'BACKGROUND', 'citation': 'Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. doi: 10.1097/01.prs.0000201478.64877.87.'}, {'pmid': '12900604', 'type': 'BACKGROUND', 'citation': 'Nahabedian MY, Tsangaris T, Momen B, Manson PN. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg. 2003 Aug;112(2):467-76. doi: 10.1097/01.PRS.0000070727.02992.54.'}, {'pmid': '26858758', 'type': 'BACKGROUND', 'citation': 'Caviggioli F, Maione L, Klinger F, Lisa A, Klinger M. Autologous Fat Grafting Reduces Pain in Irradiated Breast: A Review of Our Experience. Stem Cells Int. 2016;2016:2527349. doi: 10.1155/2016/2527349. Epub 2015 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.\n\nThere are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.\n\nAdjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.\n\nDespite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.\n\nHowever, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.\n\nIn particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.\n\nThe aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of some Breast Units in Italy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)\n\nExclusion Criteria:\n\n* Delayed prosthetic reconstruction'}, 'identificationModule': {'nctId': 'NCT04783818', 'briefTitle': "Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction", 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Clinical and Research Center'}, 'officialTitle': "Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction", 'orgStudyIdInfo': {'id': '49/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'One Stage Reconstruction With Adjuvant Radiotherapy', 'interventionNames': ['Radiation: Adjuvant Radiotherapy']}, {'label': 'Two Stage Reconstruction With Adjuvant Radiotherapy', 'interventionNames': ['Radiation: Adjuvant Radiotherapy']}, {'label': 'Autologous Reconstruction With Adjuvant Radiotherapy', 'interventionNames': ['Radiation: Adjuvant Radiotherapy']}, {'label': 'One Stage Reconstruction Without Adjuvant Radiotherapy'}, {'label': 'Two Stage Reconstruction Without Adjuvant Radiotherapy'}, {'label': 'Autologous Reconstruction Without Adjuvant Radiotherapy'}], 'interventions': [{'name': 'Adjuvant Radiotherapy', 'type': 'RADIATION', 'description': 'PMRT', 'armGroupLabels': ['Autologous Reconstruction With Adjuvant Radiotherapy', 'One Stage Reconstruction With Adjuvant Radiotherapy', 'Two Stage Reconstruction With Adjuvant Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Marco Klinger', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Humanitas Hospital, Italy'}, {'name': 'Davide Franceschini', 'role': 'STUDY_CHAIR', 'affiliation': 'Humanitas Hospital, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Clinical and Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marco Klinger', 'class': 'UNKNOWN'}, {'name': 'Marta Scorsetti', 'class': 'UNKNOWN'}, {'name': 'Davide Franceschini', 'class': 'UNKNOWN'}, {'name': 'Emanuela Morenghi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrea Lisa', 'investigatorAffiliation': 'Humanitas Clinical and Research Center'}}}}