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

Completed · Not applicable

Conditions studied: Rectal Cancer

In brief

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 (CRT). 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.

Key facts

Study ID

NCT01226979

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

16

Starts

2010-10-26

Expected to finish

2018-07-31

Last updated by the study team

2025-02-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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