A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
The proposed protocol aims to continue tumor-directed therapy during the typical "break
period" in an effort to improve on both local tumor response as well as distant disease
control. First, the duration from completion of chemoradiotherapy would increase from 6-8
weeks to 9-11 weeks. As noted above, this may allow for further cell death with resultant
pathologic downstaging. Secondly, the protocol calls for continued systemic therapy during
the 9-11 week period, thus allowing continuation of therapies directed towards both the
primary as well as distant sites of disease. The primary aim of this pilot study would be
to establish the feasibility of this intensified neoadjuvant approach, especially with
respect to tolerability of the subsequent pelvic surgery. A subsequent phase II portion
will evaluate the efficacy of this treatment approach.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary study endpoint for the phase I portion of this study is to assess surgical complications through the Clavien grading system.
The adverse events will be followed prospectively from the date of surgery for 90 days. Dose-limiting toxicity (DLT) will be defined as > grade 3 anastomotic stricture or leak, infection (including pelvic abscess or wound infection), small bowel obstruction, or fistualization. Any other post-operative complication thought related directly to the surgical intervention that is a grade 3 or higher Clavien complication will also be considered dose-limiting toxicity.
Jeffrey Meyer, MD
UT Southwestern Medical Center Dallas
United States: Institutional Review Board
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