Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer
Status:
Active, not recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Danish Gynecological Cancer Group
Collaborators:
Arbeitsgemeinschaft Gynaekologische Onkologie Austria Belgian Gynaecological Oncology Group Central and Eastern European Oncology Group European Organisation for Research and Treatment of Cancer - EORTC Israeli Society of Gynecologic Oncology Mario Negri Gynecologic Oncology group (MaNGO) Mario Negri Gynecologic Oncology group (MaNGO) Italy Mayo Clinic Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITTO) Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO) Germany Nordic Society for Gynaecologic Oncology Nordic Society of Gynaecological Oncology - Clinical Trials Unit North Eastern German Society of Gynaecological Oncology