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Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03083314
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
This is a pilot study at the National Cancer Institute (INT) of Milan evaluated the feasibility of selective axillary dissection (SAD) which preserved the lymphatic drainage of the arm. Lymph nodes draining the arm are identified following radiotracer injection and lymphoscintigraphy, a technique called axillary reverse mapping (ARM). SAD was found feasible in 75% of patients. Furthermore only 9% had BCRL after SAD compared to 33% after axillary lymph node dissection (ALND).

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD) Procedure: COMPLETE AXILLARY DISSECTION (ALND) Not Applicable

Detailed Description:
To evaluate the efficacy, safety and cost reduction of SAD compared to standard ALND, we propose a prospective 2-arm randomised trial. The control arm consists of patients randomized to ALND, the study arm consists of patients randomized to SAD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study is a 2-arm (1:1 allocation) prospective randomised trial. The control arm consists of patients randomized to ALND, the study arm is patients randomized to SAD.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SELECTIVE AXILLARY LYMPH NODE DISSECTION VS COMPLETE AXILLARY DISSECTION: A RANDOMISED CLINICAL TRIAL TO ASSESS THE PREVENTION OF LYMPHEDEMA IN BREAST CANCER TREATMENT
Actual Study Start Date : June 12, 2014
Estimated Primary Completion Date : June 2, 2017
Estimated Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD) Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
Active Comparator: COMPLETE AXILLARY DISSECTION (ALND) Procedure: COMPLETE AXILLARY DISSECTION (ALND)



Primary Outcome Measures :
  1. To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND) [ Time Frame: 36 months ]
    For this purpose patients enrolled will receive a physical assessment one month after surgery, with evaluation at 6 and 12 months after surgery that includes oncological assessment, physical assessment, lymphoscintigraphy, and self-evaluation questionnaire to assess the presence BCRL.


Secondary Outcome Measures :
  1. Safety of the selective axillary dissection (SAD) procedure by assessing the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes. [ Time Frame: 36 months ]
    to assess the potential for residual disease in the axilla after SAD by evaluating the status, in the ALND arm, of nodes that are spared and assess the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes.


Other Outcome Measures:
  1. To compare costs in the axillary lymph node dissection (ALND) and selective axillary dissection (SAD) arms [ Time Frame: 36 months ]
    To compare costs in the ALND and SAD arms including: lymphoscintigraphy, time required for surgery, and treatments required for lymphedema during follow up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with operable breast cancer who are candidates for ALND, irrespective of the type of breast surgery performed or adjuvant treatments administered.
  • 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:

  • Massive axillary metastasis (N2 AJCC).
  • Previous surgery to controlateral axillary region.
  • Previous radiotherapy to ipsilateral or controlateral regional lymph nodes.
  • Non compliance with any inclusion criterion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083314


Contacts
Contact: Massimiliano Gennaro, MD +390223903246 massimiliano.gennaro@istitutotumori.mi.it

Locations
Italy
Massimiliano Gennaro Recruiting
Milan, Italy, 20133
Contact: Massimiliano Gennaro, MD    +390223903246    massimiliano.gennaro@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications of Results:

Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03083314     History of Changes
Other Study ID Numbers: RF-2013-02355260
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases