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Gynecologic Cancer Trials

UC13-1235: A Randomized Placebo Controlled Phase II Trial of Metformin in Conjunction with Chemotherapy
Aims: The purpose of this study is to see if participants who receive 6 cycles of carboplatin plus either paclitaxel or docetaxel (standard chemotherapy ) plus metformin followed by metformin alone continued after the chemotherapy will have an improved outcome compared to those receiving 6 cycles of carboplatin plus either paclitaxel or docetaxel (standard chemotherapy) plus placebo followed by placebo alone continued after chemotherapy.  
Diagnosis: Ovarian, fallopian tube or primary peritoneal cancer (cancer of the lining of the abdomen) for which you have already undergone surgery
Principal Investigator: Gustavo Rodriguez, MD
IRB Approval Number: EH14-274
Sponsor: University of Chicago
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

Pilot Study of the Impact of Early Palliative Care on Quality of Life in Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Aims: The purpose of this study is to see if participants who see Palliative Care physicians at an earlier timepoint have a better quality of life.  
Diagnosis: Ovarian, fallopian tube or primary peritoneal cancer (cancer of the lining of the abdomen) for which you have already had treatment
Principal Investigator: Elena Moore, MD
IRB Approval Number: EH15-193
Sponsor: NorthShore
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

NRG-GY019: A Randomized Phase III, Two -Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum.
Aims: The purpose of this study is to see if the addition of letrozole used either by itself or in addition to usual chemotherapy will lower the chance of the cancer growing or spreading.
Diagnosis: Serous Ovarian Cancer
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH21-037
Sponsor: NRG Oncology
ontact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: Yes

NRG-GY020: A Randomized Phase III Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mistmatch Repair Deficient (DMMR) Endometrioid Endometrial Cancer (NCT# 04214067)
Aims: The purpose of this study is to compare the usual treatment alone (radiation) to using the usual treatment plus pembrolizumab (immunotherapy) to see which is better.  
Diagnosis: Endometrial Cancer
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH20-276
Sponsor: NRG Oncology
Contact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: Open

AGCT-1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
Aims: The purpose of this study is if active surveillance is an acceptable method of monitoring patients with germ cell tumors. If the cancer is standard risk, the trial is testing which chemotherapy is better.
Diagnosis: Germ Cell tumors
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH17-350
Sponsor: Children's Oncology Group
Contact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: Yes

NRG-GY009: A Randomized Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Peglyated Liposomal Doxorubicin/Bevaciuzmab in Platinum Resistant Ovarian Cancer
Aims: The purpose of this study is to see if the addition of atezolizumab to standard therapy is better than standard therapy alone.
Diagnosis: Ovarian, fallopian tube or primary peritoneal cancer (cancer of the lining of the abdomen)
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH18-322
Sponsor: NRG Oncology
Contact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: Open

NRG-GY014: A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma
Aims: The purpose of this study is to see Tazemetostat will lower the chances of ovarian or endometrial cancers growing.
Diagnosis: Ovarian, fallopian tube or primary peritoneal cancer (cancer of the lining of the abdomen)
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH19-275
Sponsor: NRG Oncology
Contact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: SUSPENDED

NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer
Aims: The purpose of this study is to see if the addition of pembrolizuamb to the standard of care drugs are better than standard of care drugs aloneherapy in controlling endometrial cancer.
Diagnosis: Endometrial Cancer
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH20-036
Sponsor: NRG Oncology
ontact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: suspended

NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Amonth BRCA1 Carriers (SOROCk)
Aims: The purpose of this study is to see if the removal of only fallopian tubes is no different than removal of the fallopian tubes and ovaries in ovarian cancer risk reduction.
Diagnosis: Ovarian, fallopian tube or primary peritoneal cancer (cancer of the lining of the abdomen)
Principal Investigator: Gustavo Rodriguez, MD
IRB Approval Number: EH20-324
Sponsor: NRG Oncology
Contact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: Open

GOG-3026: A Phase II Trial of Ribociclib (LEE011) plus Letrozole in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Aims: The purpose of this study is to test any good and bad effects of the study drug, ribociclib when used with letrozole to treat low-grade serous carcinoma of the ovary or peritoneum
Diagnosis: Ovarian or primary peritoneal cancer (cancer of the lining of the abdomen)
Principal Investigator: Mary Tilley Jenkins-Vogel, MD
IRB Approval Number: EH18-395
Sponsor: Gynecologic Oncology Group
Contact: Interested patients should contact research nurse Tara Flangan at 847.570.1768 or e-mail tflanagan@northshore.org.
Open to Enrollment: Open