September 14 2021
September is Gynecologic Cancer Awareness Month and, in honor of this month, NRG Oncology is highlighting some of our recently activated or reopened NRG Oncology Gynecologic Cancer trials:
NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer. This trial was temporarily closed to accrual May 28, 2021 due to a shortage of Triapine. The agent is available again and the trial has re-opened effective August 31, 2021. Documents are available on the CTSU website
NRG-GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer.: A Platform Trial for Women with Recurrent or Persistent Endometrial Cancer. This trial re-opened with new cohorts effective August 16, 2021. It now compares the efficacy of the combination of olaparib and AZD5363 (capivasertib), and the combination of olaparib and durvalumab (MEDI4736), and the combination of cediranib and durvalumab (MEDI4736) versus single agent cediranib as measured by overall survival (OS), in patients with recurrent, persistent or metastatic endometrial cancer. Documents are available on the CTSU website
NRG-GY024: Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial is a US Participation Appendix which was developed to allow participation on the Dutch Gynecologic Oncology Group (DGOG) Protocol GROINSS-V III 18May20 Version 13. It has opened to patient entry effective August 31, 2021. The US Participation Appendix, US Consent form and DGOG Protocol are approved by the NCI Central Institutional Review Board (CIRB) and are available on the CTSU website.