Trial name or title	A Phase III intergroup trial on adjuvant therapy in radically operated endometrial cancer patients with high risk for micro-metastatic disease: 4 courses of adjuvant carboplatin/paclitaxel followed by radiation therapy versus 2 more courses of carboplatin/paclitaxel
Methods	Women are treated according to randomisation to either adjuvant radiotherapy (48.6 Gray in 1.8 Gray fractions) + para-aortic irradiation if pelvic N+ and para-aortal nodes NX or N+ or 2 additional cycles of adjuvant CT (carboplatin and paclitaxel) The randomisation occurs after surgery and before the routine adjuvant chemotherapy. Vaginal brachytherapy is added if stage II or higher with cervical engagement if extended hysterectomy with parametrial resection has not been performed
Participants	Women treated by hysterectomy, four courses of chemotherapy (carboplatin and paclitaxel) for histologically confirmed endometrial carcinoma (endometrioid, adenosquamous, serous or clear cell carcinoma) with no macroscopic remaining tumour after primary surgery (lymph node exploration optional), with one of the following postoperative FIGO 2009 stage and grade: a. stage IB grade 3, nodes not explored. c. Stage II all grades d. Stage IIIC1-2 (based only on positive nodes with no macroscopic remaining tumour) WHO-performance status 0-2;
Interventions	After randomisation all patients receive four courses of CT (carboplatin and paclitaxel). Thereafter women are treated according to randomisation Arm 1: Adjuvant radiotherapy (48.6 Gray in 1.8 Gray fractions) + para-aortic irradiation if pelvic N+ and para-aortal nodes NX or N+ Arm 2: 2 additional cycles of adjuvant CT (carboplatin and paclitaxel) Vaginal brachytherapy is added if stage II or higher with cervical engagement if extended hysterectomy with parametrial resection has not been performed
Outcomes	Primary: Overall survival (OS) Secondary: Progression-free survival (PFS), Failure-free survival (FFS; defined as relapse or death from endometrial carcinoma or of treatment complications, deaths of intercurrent causes censored), treatment toxicity, quality of life, translational research of predictive or prognostic factors
Starting date
Contact information	Thomas Hogberg, Department of Cancer Epidemiology, University Hospital, SE-221 85 Lund, Sweden. thomas.Hogberg@med.lu.se
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