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

This study is currently recruiting participants.
Verified May 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01226979
First received: September 21, 2010
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given. With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it.


Condition Intervention Phase
Rectal Cancer
 Radiation: High-dose endorectal brachytherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Evaluate the pathological response rates associated with HDRBT [ Time Frame: from treatment until response ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: High-dose endorectal brachytherapy
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226979

Contacts
Contact: Joseph M Herman, M.D. 410-502-3823 jherma15@jhmi.edu
Contact: Beth Griffith, B.S.N. 410-502-9243 mgriffi3@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21231
Contact: Beth Griffith, B.S.N.     410-502-9243     mgriffi3@jhmi.edu    
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Joseph M Herman, M.D. Johns Hopkins Department of Radiation Oncology
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01226979     History of Changes
Other Study ID Numbers: J0977, NA_00029263
Study First Received: September 21, 2010
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
rectal cancer
high dose endorectal brachytherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013