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Brachytherapy
HDR Brachytherapy for Prostate Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dos...
Secondary outcome measures
To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB
To increase the flow of oncology patients requiring brachytherapy to the NCI ROB, as these patients lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, ...
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Radiation TherapyExperimental Treatment1 Intervention
Radiation therapy given as HDR Brachytherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HDR Brachytherapy
2014
N/A
~100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,893 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,983 Patients Enrolled for Prostate Cancer
Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
658 Total Patients Enrolled
4 Trials studying Prostate Cancer
326 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cervical cancer.I have lung cancer.My cancer has returned at the top part of my vagina.My endometrial cancer cannot be removed by surgery.I cannot have surgery and need treatment for cervical cancer that cannot be removed.I have advanced cervical cancer and will receive brachytherapy as part of my treatment.I am able to follow the treatment plan as directed.I have abnormal bleeding times or am on blood thinners.Nothing in my body prevents safe use of internal radiation therapy.I am older than 18 years.I can take care of myself and am up and about more than half of my waking hours.My condition is a type of gynecologic cancer.I am unable to understand or sign the consent form due to cognitive issues.I have received chemotherapy within 5 days before my brachytherapy.My cancer type does not meet the study's specific requirements.My breast cancer is early stage and the tumor is 3.0 cm or smaller.I have prostate cancer that hasn't spread far and will be treated with targeted radiation.My cancer is confirmed and can be treated with a specific radiation therapy.I have symptoms due to a lung issue.I cannot have surgery due to poor lung function or cancer spread in my lungs.I have endometrial cancer.I have prostate cancer.I have breast cancer.I am receiving or have received HDR therapy for my breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can the clinical trial accommodate?
"Affirmative, the clinical trials website shows that this research project is currently in need of participants. The trial was first published on April 14th 2009 and revised most recently on November 19th 2022. 112 individuals are being recruited from 2 separate medical sites."
Answered by AI
Is HDR Brachytherapy a risk-free procedure for individuals?
"HDR Brachytherapy is classified as a 2, since research has indicated its safety but there isn't any data that conclusively proves efficacy."
Answered by AI
Is enrollment currently available for this experiment?
"Per clinicaltrials.gov, this research endeavour is actively in search of test subjects. It was launched on April 14th 2009 and the latest update occurred on November 19th 2022."
Answered by AI
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