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Brachytherapy

HDR Brachytherapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Deborah E Citrin, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than 18 years of age
ECOG performance status of 0, 1, or 2
Must not have
Abnormal bleeding times or active anti-coagulation therapy
Cognitively impaired participants who cannot give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 16 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. The treatments will take place in the Radiation Oncology Clinic, and the number of treatments will vary according to the individual needs and requirements of each type of cancer and each patient.

Who is the study for?
This trial is for adults over 18 with various cancers (like endometrial, cervical, esophageal, biliary, prostate) who may benefit from high-dose brachytherapy. Participants must be in relatively good health and have a primary oncologist to collaborate on their care. They should agree to use birth control if they can have children.
What is being tested?
The study tests high-dose rate brachytherapy—a type of internal radiation therapy—on patients with specific cancers. It involves placing devices inside or near the tumor area and delivering concentrated radiation directly to the cancer cells.
What are the potential side effects?
Potential side effects include localized pain or discomfort where the device is inserted, skin irritation around treatment areas, fatigue due to radiation exposure, and possible short-term urinary or bowel changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer is confirmed and can be treated with a specific radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have abnormal bleeding times or am on blood thinners.
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I am unable to understand or sign the consent form due to cognitive issues.
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My cancer type does not meet the study's specific requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 16 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 16 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall
Secondary study objectives
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall
Number of Participants Accrued Who Received Brachytherapy Each Year
Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall
+1 more
Other study objectives
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Radiation TherapyExperimental Treatment4 Interventions
Radiation therapy given as high dose radiation (HDR) Brachytherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810
CT
2017
Completed Phase 3
~3270
PET Scan
2006
Completed Phase 3
~610

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,989 Total Patients Enrolled
Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
755 Total Patients Enrolled

Media Library

HDR Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00924027 — Phase 2
Esophageal Cancer Research Study Groups: 1/Radiation Therapy
Esophageal Cancer Clinical Trial 2023: HDR Brachytherapy Highlights & Side Effects. Trial Name: NCT00924027 — Phase 2
HDR Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00924027 — Phase 2
~3 spots leftby Nov 2025
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