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Brachytherapy + Chemotherapy for Rectal or Anal Cancer
Study Summary
This trial is testing how much radiation is safe to give to anal/rectal cancer patients during brachytherapy treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My kidney function is within the normal range.I am 18 years old or older.I will not have surgery for my condition as part of this study.My liver functions are within the normal range, or I have Gilbert's Syndrome with acceptable levels.My heart is healthy with no severe disease or arrhythmias, and my tumor is no larger than 7 cm.My cancer in the rectum or anus has been confirmed by a lab test.I am eligible for a specific radiation therapy with enough white blood cells and platelets.I am using or willing to use birth control during and up to one year after treatment.I can take care of myself and am up and about more than half of my waking hours.I am currently pregnant.It has been over 4 weeks since my last major surgery or radiation treatment.I cannot have general anesthesia due to health risks.I have had radiation therapy to my pelvis before.I can receive chemotherapy through an IV or as a pill.
- Group 1: endorectal brachytherapy, concurrent chemo and questionnaires
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are individuals currently able to sign up for this clinical experiment?
"According to clinicaltrials.gov, this medical trial has ceased recruitment as of June 13th 2022, despite having been first posted on July 1st 2014. Fortunately, there are presently 393 alternative trials recruiting volunteers at the moment."
Has the FDA given authorization to administer endorectal brachytherapy?
"The safety of endorectal brachytherapy has been evaluated and given a rating of 1, as it is currently in its Phase 1 trial stage. This indicates that data supporting both efficacy and safety are limited."
Have any other experiments been conducted with endorectal brachytherapy as a focus?
"Endorectal brachytherapy was initially studied in 2005 at Withington Hospital, with a total of 721 completed studies since then. Currently, 334 trials are enrolling patients and many of these interventions are taking place in Rockville Centre, NY."
To what extent has the trial been populated by participants?
"At this juncture, participants are not being sought for the trial. It was initially posted on July 1st 2014 and recently revised as of June 13th 2022. Fortunately, there are currently 59 studies recruiting for anal cancer patients and another 334 related to endorectal brachytherapy that require enrolment."
How many sites within the state are hosting this empirical exploration?
"Presently, this trial is running at 7 locations including Rockville Centre, Uniondale and Harrison. It may be beneficial to choose the medical centre closest you in order to streamline travelling needs if you choose to participate."
To what treatments is endorectal brachytherapy typically employed?
"Endorectal brachytherapy can be employed to combat the growth of malignant neoplasms, pancreatic endocrine carcinomas, and colorectal carcinoma."
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