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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 10, 2013
Last verified: June 2013

September 21, 2010
June 10, 2013
September 2010
September 2020   (final data collection date for primary outcome measure)
Evaluate the pathological response rates associated with HDRBT [ Time Frame: from treatment until response ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01226979 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
Phase II Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2020
September 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Joseph M Herman, M.D. 410-502-3823 jherma15@jhmi.edu
Contact: Beth Griffith, B.S.N. 410-502-9243 mgriffi3@jhmi.edu
United States
 
NCT01226979
J0977, NA_00029263
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Joseph M Herman, M.D. Johns Hopkins Department of Radiation Oncology
Sidney Kimmel Comprehensive Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP