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NCT01226979 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
NA
Development phase
16
Enrollment target

NCT01226979: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT01226979 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01226979, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
NA
Development phase
16 participants
Enrollment target

Study 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 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.

Primary Outcome

Those participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and di

Interventions

  • RADIATION High-dose endorectal brachytherapy (HDRBT)

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2010-10-26
Est. Completion 2018-07-31
Phase NA

What the finished NCT01226979 record still lists

NCT01226979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which High-dose endorectal brachytherapy (HDRBT) is the first listed.

NCT01226979 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01226979 about?

NCT01226979 is a clinical study titled "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 rectu...

What is the current status of trial NCT01226979?

This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2010-10-26. Estimated completion is 2018-07-31.

What interventions are being tested in trial NCT01226979?

The interventions under investigation include: High-dose endorectal brachytherapy (HDRBT) (RADIATION).

Who is sponsoring clinical trial NCT01226979?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01226979's enrollment target sits among peer trials

16 1871st of 2000 higher than 120 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01226979, the US trial registry maintained by the National Library of Medicine. NCT01226979 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.