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New treatment option for Endometrial Clear Cell Adenocarcinoma
Official title Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
ClinicalTrials.gov ID: NCT03422198
What this study is testing
- What it's testing
- This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.
- 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
Adults
You may be able to join if
- Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are...
- Stage IA, grade 1 with LVSI, 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
You likely can't join if
- Stages of endometrial carcinoma other than described.
- Previous pelvic radiotherapy.
- Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
See the full eligibility criteria
- Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is...
- Stage IA, grade 1 with LVSI, 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
- Participants post-hysterectomy and free from residual disease.
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Life expectancy of \>2 years.
- Stages of endometrial carcinoma other than described.
- Previous pelvic radiotherapy.
- Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Maywood, Illinois, United States
- Houston, Texas, United States
- Salt Lake City, Utah, 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 all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Maywood, Illinois, United States; Houston, Texas, United States; Salt Lake City, Utah, 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.