Phase 2
N=93
Image-Guided Gynecologic Brachytherapy
Cervical Cancer · Uterine Cancer · Vaginal Cancer · Carcinoma of the Vulva
Bottom Line
View on ClinicalTrials.gov: NCT01399658 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Mean Doses Given — 93.9; 63.2; 58.63 Gy
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Image-guided brachytherapy (Procedure); 3'-Deoxy-3'-18f-Fluorothymidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Doses Given |
93.9; 63.2; 58.63 | — |
Summary
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
- Life expectancy > 6 months
- MRI of the pelvis and/or PET-CT within 4 months prior to entering study
Exclusion Criteria
- Uncontrolled intercurrent illness
- Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Data sourced from ClinicalTrials.gov (NCT01399658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.