Status: Open
Activation Date: 2022DEC19
Phase: II
Description: A Phase II Study of Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype/NSMP Early Stage Endometrial Cancer (RAINBO BLUE & TAPER)
Eligibility: Sub-study A, Cohort A1: with early-stage POLE-mutated EC; Sub-study A, Cohort A2-Exploratory: with higher-risk POLE-mutated EC; Sub-study B: with p53wt/NSMP ER+ EC
Objective: Primary Objective: Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status
Participation: Open to member centres
Lay Description: This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) in early-stage endometrial cancer (EC). The purpose of the study is to identify women who may not require additional treatment or may require less treatment because they are at such a low risk of recurrence.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | EN10 | Open Trial | 45 | 5 | 50 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GYNECOLOGIC | EN10 | Open Trial | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GYNECOLOGIC | EN10 | Open Trial | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |