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New treatment option for Endometrial Cancer
Official title Vaginal Cuff Brachytherapy Fractionation Study
ClinicalTrials.gov ID: NCT03785288
What this study is testing
- What it's testing
- The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
- Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.
- Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and...
- people must have no measurable disease after surgery.
- ECOG Performance Status of 0-2
You likely can't join if
- Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
- Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned
- people who have not recovered from side effects of agents administered more than 4 weeks prior to the on-study date
- people that require \> 14 weeks between surgery and initiation of radiation therapy on study unless the subject is receiving chemotherapy. people...
- people who are receiving any investigational agents or have had any investigational agent within the 30 days prior to the on-study date
- Subject is unable or unwilling to participate in a study-related procedure
See the full eligibility criteria
- Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
- Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.
- Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma histologic pathologies are allowed.
- people must have no measurable disease after surgery.
- ECOG Performance Status of 0-2
- Age ≥ 18 years
- Subject must have a life expectancy ≥ 12 months
- Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
- Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned
- people who have not recovered from side effects of agents administered more than 4 weeks prior to the on-study date
- people that require \> 14 weeks between surgery and initiation of radiation therapy on study unless the subject is receiving chemotherapy. people receiving chemotherapy may have radiation therapy initiated within 6...
- people who are receiving any investigational agents or have had any investigational agent within the 30 days prior to the on-study date
- Subject is unable or unwilling to participate in a study-related procedure
- Pregnant and breastfeeding women are excluded from this study
- Subject is a prisoner
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
- people with a history of evidence upon physical examination of central nervous system disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Syracuse, New York, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Syracuse, New York, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.