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.

Inclusion Criteria:

- Patients with histologically confirmed adenocarcinoma of the rectum

- Able to undergo local staging of the rectal tumor performed by MRI and/or EUS
demonstrating a T2N1 or T3N0-1 tumor

- ECOG performance status of 0 or 1

- Participants are willing to undergo initial therapy and if needed subsequent therapy
prior to resection at Johns Hopkins Medical Institutions

- English as a primary language in order to complete the quality of life questionnaires

Exclusion Criteria:

- Patients with tumors >12 cm from the anal verge.

- Near obstructing or bulky tumors which will not allow application of the endorectal
probe

- Patients with distant metastatic disease

- Any pelvic lymph nodes outside of the mesorectum (iliac or inguinal)

- Prior history of radiation therapy to the pelvis

- Prior history of chemotherapy for rectal cancer

- Active connective tissue disease such as scleroderma or Crohn's disease