Multiparametric ultrasound to examine vaginal tissue in people with endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will undergo multiparametric ultrasound (mpUS) imaging of the vagina before and after intravaginal radiotherapy (IVRT) to document tissue changes. Imaging results will be compared with a standardized vaginal assessment score (VAS) and clinical findings to characterize vaginal toxicity such as dryness, stenosis, and fibrosis. The study will also record whether participants can tolerate all mpUS procedures to determine feasibility. Eligible patients are adults with surgically staged FIGO 2009 stage I–II endometrial carcinoma who had complete resection and are scheduled to start IVRT within 12 weeks of surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Consent Only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent Only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Consent Only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent Only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kaled Alektiar, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Kaled Alektiar, MD
• Email: alektiak@mskcc.org
• Phone: 212-639-7981

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.