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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)

Overall Status

Completed

CT.gov ID

NCT03083314

Collaborator

(none)

130

Enrollment

Location

Arms

77.8

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

130 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.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 :

Jun 12, 2014

Actual Primary Completion Date :

Nov 15, 2018

Actual Study Completion Date :

Dec 4, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND) [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

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. [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

To compare costs in the axillary lymph node dissection (ALND) and selective axillary dissection (SAD) arms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massimiliano Gennaro	Milan		Italy	20133

Sponsors and Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

ClinicalTrials.gov Identifier:

NCT03083314

Other Study ID Numbers:

RF-2013-02355260

First Posted:

Mar 20, 2017

Last Update Posted:

Apr 9, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Lymphedema

Study Results

No Results Posted as of Apr 9, 2021