drugset / Trial / NCT01244789
Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer
Phase 2
Active not recruiting
244 enrolled
Danish Gynecological Cancer Group
Arbeitsgemeinschaft Gynaekologische Onkologie Austria · collabBelgian Gynaecological Oncology Group · collabCentral and Eastern European Oncology Group · collabEuropean Organisation for Research and Treatment of Cancer - EORTC · collabIsraeli Society of Gynecologic Oncology · collabMario Negri Gynecologic Oncology group (MaNGO) · collabMulticenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) · collabNordic Society of Gynaecological Oncology - Clinical Trials Unit · collabNorth Eastern German Society of Gynaecological Oncology · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
Patients with stage 1 \& 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown survival benefit in more advanced stage disease (stage 3 \& 4). This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy). Substudy: Translational research
Timeline
- Start
- 2011-12
- Primary completion
- 2028-07-01
- Completion
- 2028-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |