Status:
WITHDRAWN
Brachytherapy Innovations in Gynecologic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18-80 years
Brief Summary
In this pilot study, the investigators will test tools designed to more precisely identify, define and create a radiation treatment plan to tumor remnants as separate from fibrotic or normal tissue in...
Detailed Description
This study is a clinical research study following patients for toxicity after brachytherapy, and the investigators will be using the D2cc as a surrogate biomarker for determining risk for toxicity in ...
Eligibility Criteria
Inclusion
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins.
- Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
- Carcinoma of the cervix: Stage I-IVA or vaginal recurrence Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence Carcinoma of the vagina: Stage I-IVA or vaginal recurrence Carcinoma of the vulva: Stage I-IVA or recurrence Carcinoma of the urethra based on treating physician's discretion
- Patients who have received prior radiation or chemotherapy may be enrolled on this study.
- Age \> 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
- Life expectancy of greater than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG status of \<2, based on treating physician's discretion
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Absolute neutrophil count \< 500 at the time of brachytherapy
- A history of metal in the head or eyes
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2032
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04530019
Start Date
October 1 2024
End Date
December 1 2032
Last Update
November 29 2024
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