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Phase II Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer

Phase 2
18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the pathological response rates associated with HDRBT

Outcome Time Frame:

from treatment until response

Safety Issue:


Principal Investigator

Joseph M Herman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Department of Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

September 2020

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • high dose endorectal brachytherapy
  • Rectal Neoplasms



Johns Hopkins Medical Institutions Baltimore, Maryland  21205