Gynecologic Oncology Trials

NRG Oncology is a non-profit research organization formed to conduct oncologic clinical research and to broadly disseminate study results for informing clinical decision making and healthcare policy. It brings together the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG)—each recognized internationally as a research leader.

NRG Oncology embodies an impressive legacy in the conduct of multi-institutional phase II and phase III clinical trials and a history of undertaking phase I and translational biological studies imperative for oncologic research of the future.

Approximately 25 individual clinical trials are active at any one time for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. NRG Oncology and the GOG Foundation partner with the Foundation for Women’s Cancer to promote clinical trials participation and provide easy-to-access information about clinical trials that currently are open for enrollment.

Current Gynecologic Oncology Trials:

GOG0 213 A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination with Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytopreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912) (Robert Coleman)

GOG 0225 Can Diet and Physical Activity Modulate Ovarian or Primary Peritoneal Cancer Progression-Free Survival? (David S Alberts)

GOG 0229O A randomized phase II study with a phase I lead-in to assess the antitumor efficacy of the MEK inhibitor Trametinib alone or in combination with GSK2141795, an AKT inhibitor in patients with recurrent or persistent endometrial cancer. (Shannon N Westin)
GOG 0237 Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC) (Shu-Yuan Liao)

GOG 0238 A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine Corpus (Higinia R Cardenes)

GOG 0260 A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (IND 110072) (NCT# 00888615) (Bradley J Monk)

GOG 0263 Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA, Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphdenectomy. (Sang-Young Ryu)

GOG 0264 A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemo-Naive Sex Cord-Stromal Tumors of the Ovary. (Jubilee Brown)

GOG0265 A Phase II Evaluation of ADXS11-001 (IND #13,712) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix (NCT# 01266460) (Warner K Huh)

GOG 0270 Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V)II: An Observational Study (Brian M Slomovitz)

GOG 0274 A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial (ANZGOG 0902/GOG-0274/RTOG 1174) (Kathleen N Moore)

GOG 0275 A Phase III Randomized Trial of Pulse Actinomcyin-D versus Multi-day Methotrexate for the Management of Low Risk Gestational Trophoblastic Neoplasia (NCT# 01535053) (Julian C Schink)

GOG 0277 A Phase III Randomized Trial of Gemcitabine (NSC# 613327) plus Docetaxel (NSC# 628503) followed by Doxorubicin (NSC# 123127) v. observation for uterus-limited, High Grade Uterine Leiomyosarcoma (NCT# 01533207) (Martee L Hensley)

GOG 0278 Evaluation of Physical Function and QoL Before and After Non-Radical Surgical Therapy for Stage IA1 (LVSI+) and IA2-IB1 Cervical Cancer (NCT# 01649089) (Allan L Covens)

GOG 0279 A Phase II Trial Evaluating Cisplatin and Gemcitabine Concurrent with Intensity-Modulated Radiation Therapy (IMRT) for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva (NCT# 01595061) (Neil S Horowitz)

GOG 0281 A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK1120212) in Patients with Recurrent or Progressive Low-grade Serous Ovarian Cancer or Primary Peritoneal Cancer (David M Gershenson)

GOG 0286B A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer (Victoria L Bae-Jump)

GOG0724 Phase III Randomized Study of Concurrent Chemotherapy and Pelvic RT With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy (RTOG # 0724) (Heidi J Gray)

GOG 3007 A Randomized Phase II TRIAL of Everolimus and Letrozole or Hormonal Therapy (Tamoxifen/Medroxyprogestrone (Acetate) in Women with Advanced, Persistent, or Recurrent Endometrial Carcinoma (Brian M Slomovitz)

GOG 9923 A Phase I Study of Carboplatin/Paclitaxel/CTEP-Supplied Bevacizumab(NSC #704865, IND #7921)and CTEP-Supplied Agent ABT-888(NSC #737664,IND# 77840)in Newly Diagnosed Patients with Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary PeritCancer (Katherine M Bell-McGuinn)

GOG 9928 A Phase I study of the safety of intraperitoneal EGEN-001 (IL-12 plasmid formulated with PEG-PEI-Cholesterol lipopolymer) administered in combination with pegylated liposomal doxorubicin (PLD) in recurrent ovarian cancer patients. The purpose of this studtermine the safety of EGEN-001 IP plus PLD treatment in platinum-recurrent ovarian cancer patients. (Ronald D Alvarez)

GOG 9929 A Phase I Trial of Sequential Ipilimumab After Chemoradiation for the Primary Treatment of Patients with Locally Advanced Cervical Cancer Stages IB2/IIA with Positive Para-aortic Lymph Nodes Only Stage IIB/IIIB/IVA with Positive Lymph Nodes (Yvonne G Lin-Liu)

NRG CC002 Preoperative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers (Amina Ahmed)

RTM 0905 E2607 A Phase II Trial of Dasatinib in KIT-Positive Patients with Unresectable Locally Advanced or Statge IV Mucosal, Acral and Vulvovaginal Melanoma. https://www.ctsu.org/public/ (Mario M Leitao)

Additional Clinical Trial Resources

Spotlight

In honor of Cervical Cancer Awareness Month, The Foundation for Women’s Cancer is featuring a video produced by the Society of Gynecologic Oncology on the HPV vaccine. The two-minute video encourages parents to get their children the vaccine.

Awareness

September is Gynecologic Cancer Awareness Month.  After creating the month in 1999, the Foundation strives to bring attention about these cancers through public awareness campaigns.

Research

The Foundation is proud to offer various Research Grants and Awards. Click here for more information.

Education

FREE Gynecologic Cancer Survivors Courses throughout the country. For more information, click here.