NCT01276054|TerminatedPhase 2ResultsDMC

Study Stopped

P.I. left

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program

University of Southern California ClinicalTrials.gov

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2 other identifiers

1B-09-12NCI-2010-02323

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2011

StartedDec 2010

CompletionOct 2011

Brief Summary

Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

December 1, 2010

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

August 1, 2014

Completed

Last Updated

August 1, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

January 11, 2011

Results QC Date

July 1, 2014

Last Update Submit

July 1, 2014

Conditions

Lymphedema Recurrent Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer

Outcome Measures

Primary Outcomes (1)

Whether or Not a Patient Has Developed Grade 1+ LE
LE is defined using the CTCAE v3 definition: a \>5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
During the first year post-operatively

Study Arms (2)

SNB plus ARM or ALND (+/- SNB) plus ARM

EXPERIMENTAL

Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.

Radiation: technetium Tc 99m sulfur colloidDrug: methylene blueDrug: indocyanine green solutionProcedure: sentinel lymph node biopsyProcedure: axillary lymph node biopsyProcedure: bioimpedance spectroscopyProcedure: quality-of-life assessmentOther: lymphedema management

SNB or ALND (+/- SNB)

ACTIVE COMPARATOR

Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.