Endometrial Cancer
Conditions
Keywords
stage I-II endometrial carcinoma
Brief summary
The researchers are doing this study to see how well multiparametric ultrasound (mpUS) imaging can evaluate vaginal tissue before and after IVRT. IVRT is routinely used to treat endometrial cancer but can cause damage to the vaginal tissue (vaginal toxicity). Side effects of vaginal toxicity can include vaginal dryness, itching, soreness, discharge, narrowing or shortening of the vagina (stenosis), and vaginal fibrosis (hardening), which can affect sexual function. The researchers will also look at whether participants are able to complete (tolerate) all mpUS imaging for this study.
Interventions
DIAGNOSTIC_TESTMultiparametric Ultrasound Imaging
multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT
OTHERThe vaginal assessment score (VAS)
The vaginal assessment score (VAS) is a four-item measure that is administered to the patient to quantify and rate (none, mild, moderate, or severe) their perception of dryness, soreness, irritation, and pain (dyspareunia or painfulness to touch with external stimulation).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This will be a prospective, single center clinical study with 10 patients with endometrial cancer to test the feasibility of using mpUS to characterize the vaginal tissue response to IVRT.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be diagnosed with a primary endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serious, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma * Initial surgical treatment must have included hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment with either sentinel lymph node mapping/sampling or pelvic lymph node dissection. Surgical assessment of the para-aortic lymph nodes is not required * Patients must have had a complete surgical resection with negative margins and no residual gross disease after surgery * Patients must have FIGO (2009) stage I-II disease (per surgical staging) * Age ≥ 18 years * Patients must be able to start radiotherapy within 12 weeks from date of surgery
Exclusion criteria
* Patients receiving chemotherapy or hormonal therapy * A prior or concurrent malignancy whose natural history or treatment would interfere with the toxicity or efficacy assessment of IVRT * Prior pelvic radiotherapy * Active genitourinary infection requiring antibiotics, except for uncomplicated urinary tract infection * History of active inflammatory bowel disease requiring treatment, including Crohn's disease and ulcerative colitis * Concurrent psychiatric or medical condition or disease which, per investigator judgement, would make them unsuitable candidates for study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of B-mode ultrasound imaging | 1 year | B-mode feasibility is defined as the ability to visualize/quantify vaginal wall thickness and echogenicity at baseline and immediately following the last IVRT treatment in 6 out of 10 patients. |
Countries
United States
Contacts
Primary ContactKaled Alektiar, MD
Backup ContactMark Burgess, MD
Outcome results
None listed