Page 12 - Delaware Medical Journal - August, 2016
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
Alliance A0011202: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel
Lymph Node Disease After Neoadjuvant Chemotherapy
Objective:
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.
Secondary Objective:
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.
For each treatment arm:
To obtain an estimate of the distribution of residual disease burden scores.
To estimate the distribution of overall survival. Correlative objectives:
To estimate the incidence of arm lymphedema.
treatment rendered to the axilla.
Eligibilty:
edition.
metastasis at the time of diagnosis.
core biopsy.
ipsilateral axillary surgery.
Treatment: All patients undergo surgery with sentinel lymph node (SLN) procedure. Intra-operative registration/randomization:
ARM 1 Vs
ARM 2
ARM 1
Vs
ARM 2
The Delaware Cancer Treatment Program (DCTP) provides medical insurance coverage to uninsured Delawareans for the treatment of cancer. Call 302-7441040 for more information.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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Del Med J | August 2016 | Vol. 88
| No. 8
