NCT02065687.

Trial name or title	Paclitaxel and carboplatin with or without metformin hydrochloride in treating participants with stage III, IV or recurrent endometrial cancer
Methods	Accural: March 2014 to September 2019 Accrual target: 540 Multicentre, phase 2/3 RCT conducted in the USA
Participants	Measurable stage III, IVA, IVB or recurrent endometrial carcinoma Histologic confirmation of endometrioid, serous adenoma, undifferentiated, clear cell, mixed cell epithelial, adenoca NOS Measurable disease by RECIST First line ‐ must not have received prior chemotherapy or targeted therapy; may have received prior RT and prior hormonal therapy
Interventions	Intervention: paclitaxel iv day 1, carboplatin iv day 1, metformin hydrochloride by mouth twice a day on days 1 to 21 (once a day in course 1). Treatment every 21 days for 6 cycles in absence of disease progression or unacceptable toxicity. Participants then receive maintenance therapy ‐ metformin hydrochloride by mouth twice a day on days 1 to 21 Comparator: paclitaxel iv and carboplatin iv as per Intervention arm and placebo by mouth twice a day on days 1 to 21 (once a day in course 1) Treatment every 21 days for 6 cycles in absence of disease progression or unacceptable toxicity
Outcomes	Primary outcomes: ‐ OS (phase II and III) ‐ PFS (phase II) Secondary outcomes: ‐ Proportion of participants responding to therapy ‐ Duration of response by treatment ‐ Adverse events ‐ Level of obesity ‐ OS in phase II ‐ PFS in phase III Other outcomes: ‐ Expression of MATE2 ‐ Incidence of PIK3 mutations/amplifications ‐ Levels of key targets of the metformin/mTOR signalling pathway ‐ Metabolic factor levels
Starting date	Study start date: March 2014 Estimated completion date: September 2019
Contact information	Victoria Bae‐Jump NRG Oncology
Notes	NCT02065687 Sponsor: Gynecologic Oncology Group