Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2018-03-12
2018-08-09
Brief Summary
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An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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radiation
intervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy
pre-operative irradiation
pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy
Interventions
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pre-operative irradiation
pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cT1-2N0 breast cancer
* cM0
* female patients ≤ 50 years
* planned breast conserving surgery
* ability to undergo irradiation and surgery
* signed written informed consent
Exclusion Criteria
* planned oncoplastic reduction mammoplasty
* cTis
* extensive calcifications on mammagram (Birads 3,4 or 5)
* cT3-4 and/or cN1-3 invasive carcinoma
* distant metastasis
18 Years
50 Years
FEMALE
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Astrid Scholten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Antoni van Leeuwenhoek
Locations
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Netherlands Cancer Institute
Amsterdam, , Netherlands
Countries
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References
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Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.
Donker M, Straver ME, Wesseling J, Loo CE, Schot M, Drukker CA, van Tinteren H, Sonke GS, Rutgers EJ, Vrancken Peeters MJ. Marking axillary lymph nodes with radioactive iodine seeds for axillary staging after neoadjuvant systemic treatment in breast cancer patients: the MARI procedure. Ann Surg. 2015 Feb;261(2):378-82. doi: 10.1097/SLA.0000000000000558.
Egro FM, Pinell-White X, Hart AM, Losken A. The use of reduction mammaplasty with breast conservation therapy: an analysis of timing and outcomes. Plast Reconstr Surg. 2015 Jun;135(6):963e-971e. doi: 10.1097/PRS.0000000000001274.
Jones HA, Antonini N, Hart AA, Peterse JL, Horiot JC, Collin F, Poortmans PM, Oei SB, Collette L, Struikmans H, Van den Bogaert WF, Fourquet A, Jager JJ, Schinagl DA, Warlam-Rodenhuis CC, Bartelink H. Impact of pathological characteristics on local relapse after breast-conserving therapy: a subgroup analysis of the EORTC boost versus no boost trial. J Clin Oncol. 2009 Oct 20;27(30):4939-47. doi: 10.1200/JCO.2008.21.5764. Epub 2009 Aug 31.
van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.
Other Identifiers
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NL59561.031.16
Identifier Type: REGISTRY
Identifier Source: secondary_id
N16PRB
Identifier Type: -
Identifier Source: org_study_id
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