Postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer: The ENGOT-EN2/DGCG trial.

Abstract

TPS5613 Background: Patients with medium and high-risk stage I and II endometrial cancers (EC) have, despite radical surgery, a high risk for progression. Adjuvant brachytherapy or EBRT is the traditional therapy for many decades although without impacting on survival. Several studies have failed to demonstrate superiority of adjuvant chemotherapy in unselected population with a high number of low-risk patients. It is of utmost importance to demonstrate efficacy of adjuvant combination chemotherapy in a randomized trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients. Methods: The primary objective of this trial is to evaluate the effect on overall survival of carboplatin-paclitaxel combination chemotherapy against no further systemic treatment. Key eligibility criteria include: histologically confirmed EC, stage I grade 3 endometrioid adenocarcinoma or stage II endometrioid adenocarcinoma or stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, carcinosarcoma or undifferentiated carcinoma); prior surgery with pelvic lymphadenectomy or sentinel lymph node biopsy. Patients may receive vaginal brachytherapy in both arms. 240 patients are randomized to receive six courses of adjuvant carboplatin (AUC5) and paclitaxel (175mg/m2) combination on day one every 21 days or no further treatment (1:1 randomization). Primary endpoint is overall survival of endometrioid subgroup. Secondary endpoints include overall survival of whole study population, disease specific survival, progression-free survival, toxicity, compliance, Quality of Life (assessed via EORTC QLQ-C30 and EORTC QLQ-EN24), rate of isolated pelvic or distant relapses, as well as mixed relapses. Trial is enrolling patients. The following cooperative groups are participating: DGCG (DK), NSGO (DK, FIN, SWE), BGOG (BEL), MaNGO (ITA), MITO (ITA), GEICO (SPA), NOGGO (GER), CEEGOG (Czech), ISGO (ISR) & MDACC (USA). Clinical trial information: NCT01244789.