Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment
NCT ID: NCT03083314
Last Updated: 2021-04-09
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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COMPLETED
NA
130 participants
INTERVENTIONAL
2014-06-12
2020-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
COMPLETE AXILLARY DISSECTION (ALND)
COMPLETE AXILLARY DISSECTION (ALND)
Interventions
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SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
COMPLETE AXILLARY DISSECTION (ALND)
Eligibility Criteria
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Inclusion Criteria
* Patients who sign the informed consent form after explanation of trial aims by a senologist involved in the study.
* Patients able to attend INT for regular follow-up as required by study protocol.
Exclusion Criteria
* Previous surgery to controlateral axillary region.
* Previous radiotherapy to ipsilateral or controlateral regional lymph nodes.
* Non compliance with any inclusion criterion.
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Locations
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Massimiliano Gennaro
Milan, , Italy
Countries
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References
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Gennaro M, Maccauro M, Sigari C, Casalini P, Bedodi L, Conti AR, Caraceni A, Bombardieri E. Selective axillary dissection after axillary reverse mapping to prevent breast-cancer-related lymphoedema. Eur J Surg Oncol. 2013 Dec;39(12):1341-5. doi: 10.1016/j.ejso.2013.09.022. Epub 2013 Oct 3.
Schunemann E Jr, Doria MT, Silvestre JB, Gasperin P Jr, Cavalcanti TC, Budel VM. Prospective study evaluating oncological safety of axillary reverse mapping. Ann Surg Oncol. 2014 Jul;21(7):2197-202. doi: 10.1245/s10434-014-3626-5. Epub 2014 Mar 6.
Agresti R, Martelli G, Sandri M, Tagliabue E, Carcangiu ML, Maugeri I, Pellitteri C, Ferraris C, Capri G, Moliterni A, Bianchi G, Mariani G, Trecate G, Lozza L, Langer M, Rampa M, Gennaro M, Greco M, Menard S, Pierotti MA. Axillary lymph node dissection versus no dissection in patients with T1N0 breast cancer: a randomized clinical trial (INT09/98). Cancer. 2014 Mar 15;120(6):885-93. doi: 10.1002/cncr.28499. Epub 2013 Dec 5.
Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.
Shah C, Wilkinson JB, Baschnagel A, Ghilezan M, Riutta J, Dekhne N, Balaraman S, Mitchell C, Wallace M, Vicini F. Factors associated with the development of breast cancer-related lymphedema after whole-breast irradiation. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1095-100. doi: 10.1016/j.ijrobp.2011.09.058. Epub 2011 Nov 16.
Ozcinar B, Guler SA, Kocaman N, Ozkan M, Gulluoglu BM, Ozmen V. Breast cancer related lymphedema in patients with different loco-regional treatments. Breast. 2012 Jun;21(3):361-5. doi: 10.1016/j.breast.2012.03.002. Epub 2012 Mar 27.
Cheville A. Prevention of lymphoedema after axillary surgery for breast cancer. BMJ. 2010 Jan 12;340:b5235. doi: 10.1136/bmj.b5235. No abstract available.
Other Identifiers
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RF-2013-02355260
Identifier Type: -
Identifier Source: org_study_id
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