Phase II Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
This study is a pilot study open to patients with clinical stage T2N1 or T3N0-1 resectable
rectal cancer. The investigational tool being evaluated is high-dose endorectal
brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation
for low rectal cancer. This study assumes that the rate of pathological response to HDRBT
will be similar to historical controls (conventional neoadjuvant chemoradiation). All
patients will receive postoperative standard 5-FU based chemotherapy (at the discretion of
the medical oncologist). The clinical response will be assessed with endoscopic/ultrasound,
pelvic MRI and FDG-PET/CT. In addition, tissue and serum will be collected to evaluate for
biological predictors of response to therapy. The endpoints of this study include adverse
events (gastrointestinal toxicity), quality of life as measured by the QLQ-C30, and tumor
regression/response.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the pathological response rates associated with HDRBT
from treatment until response
No
Joseph M Herman, M.D.
Principal Investigator
Johns Hopkins Department of Radiation Oncology
United States: Institutional Review Board
J0977
NCT01226979
September 2010
September 2020
Name | Location |
---|---|
Johns Hopkins Medical Institutions | Baltimore, Maryland 21205 |