At a glance
ClinicalIndex Comparison Record- ✓Total abdominal or laparoscopic hysterectomy with bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection
- ✓Histologically confirmed endometrioid type endometrial carcinoma, FIGO 2009 stage I with grade 3 (IA), grade 1-2 (IB), grade 3 (IB), or stage II
- ✓WHO performance status 0-2
- ✓Written informed consent
- ✕Residual disease
- ✕Other stage and type of endometrial carcinoma
- ✕Serous carcinoma, clear cell carcinoma (≥10% if mixed), undifferentiated or neuroendocrine carcinoma
- ✕Uterine sarcoma including carcinosarcoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
In Brief
A clinical study evaluating Vaginal brachytherapy, External beam radiotherapy, and 2 other interventions for Endometrial Cancer Stage I and Endometrial Cancer Stage II. Currently recruiting, targeting 590 participants across 10 sites.
Detailed Summary
This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.
Study Details
Timeline
Interventions
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy. For brachytherapy administered after completion of External beam radiotherapy (EBRT): Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )