Status:
COMPLETED
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 decreas...
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 i...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed adenocarcinoma of the rectum
- Able to undergo local staging of the rectal tumor performed by MRI and/or endoscopic ultrasonography (EUS) demonstrating a T2N1 or T3N0-1 tumor
- Eastern Cooperative Oncology Group (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
- 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
Key Trial Info
Start Date :
October 26 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01226979
Start Date
October 26 2010
End Date
July 31 2018
Last Update
February 28 2025
Active Locations (1)
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1
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21231