Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer (SOM 230)
Recruitment status was: Recruiting
The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the post-operative development of lymphocele. According to the literature, incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is inserted or a compression dressing applied and the time at which the drain is removed… In our experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients between November 2008 and February 2009]
Encouraging results in terms of reducing postoperative lymphoceles as well as drainage duration and volume using Octreotide have been recorded in two recent studies. A new molecule developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5, 5 times greater for sst3 and equivalent for sst2)
The purpose of this trial is to assess the efficacy of a pre-surgical injection of pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following axillary node dissection.
The secondary objectives are to assess the efficacy of prolonged release pasireotide on the duration of postoperative drainage, the daily drainage volume, the total drainage volume, the number of repeated lymphocele aspirations and the volume, the total volume of lymph aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of prolonged release pasireotide.
The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the incidence of symptomatic, postoperative axillary lymphoceles following mastectomy-axillary node dissection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer|
- aspirations global volume of lymphoceles [ Time Frame: 1 to 32 days after surgery ] [ Designated as safety issue: Yes ]the patients ratio who did not have post-operative axillary symptomatic lymphoceles defined as the absence of aspiration or a unique or iterative aspirations global volume of lymphoceles inferior to 60cc inclusive (≤) in the 28 days after the intervention or a systematic aspiration volume at the 28th day inferior to 120cc inclusive (≤).
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
INTRAMUSCULAR INJECTION OF PASIREOTIDE 60 MG
One INTRAMUSCULAR INECTION OF PASIREOTIDE 60 MG 10 TO 7 DAYS BEFORE SURGERY
Placebo Comparator: PLACEBO
INTRAMUSCULAR INJECTION OF PLACEBO
ONE INJECTION OF PLACEBO 10 TO 7 DAYS BEFORE SURGERY
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356862
|Paris, France, 75020|
|Institut Gustave ROUSSY|
|Villejuif, France, 94805|