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Adjuvant Chemotherapy vs Radiotherapy in High-risk Stage I Endometrial Carcinoma
NCT01820858Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Nov 2012
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- DNA Intercalators/Alkylators, Cytokines & Interferons, Fc-Fusion Proteins
- Conditions
- endometrial carcinoma
01
Overview
Phase 3, randomised, open-label trial of Paclitaxel Micelles for Injection and carboplatin in endometrial carcinoma (2 arms). Primary endpoint: Disease-free survival at 3 years. Started Nov 2012; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Adjuvant Chemotherapy
Paclitaxel + Paraplatin (Carboplatin)
Adjuvant Radiotherapy
Pelvic Radiation and/or Vaginal Brachytherapy
03
Who it enrols
Chinese women with FIGO Stage I endometrial adenocarcinoma who have undergone staging surgery and have high-risk factors (G3, deep myometrial invasion, or vascular space involvement).
04
Endpoints
Primary
Disease-free survival
Secondary
Side effect of adjuvant chemotherapy
Complications of radiotherapy
Quality of Life
Overall survival
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