Neoadjuvant Therapy for Localized Rectal Adenocarcinoma
Status:
Withdrawn
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
This study is a prospective, single-arm, single-center study of investigator's choice of
total neoadjuvant therapy (TNT) or neoadjuvant chemoradiation in locally advanced rectal
cancer. The standard of care for rectal adenocarcinomas that are triiodothyronine-thyroxine
(T3-T4) or node positive has generally been comprised of neoadjuvant chemoradiation, followed
by surgical resection and then adjuvant chemotherapy. More recently, TNT, comprised of
neoadjuvant chemotherapy and chemoradiation followed by surgical resection, has been
increasingly used as a standard therapy approach. While the use of TNT is increasingly
common, prospective study of outcomes following TNT has been limited. Moreover, there are not
any biomarkers known at this time that impact clinical decision-making or personalization of
therapy in the treatment of rectal cancer. In this study, we will collect pre-treatment
rectal adenocarcinoma specimens and determine clinical outcome, including pathologic complete
response rate, post-treatment pathologic downstaging rate, recurrence-free survival (RFS),
overall survival (OS) and neoadjuvant rectal score, among patients who are treated with
standard neoadjuvant chemoradiation or TNT, with an aim to investigate how baseline
biomarkers and changes in biomarkers with standard therapies may be associated with, and
modulate, clinical outcomes.