image: GOG-3068 (HOTT): A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin Versus No HIPEC at the Time of Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial)
Credit: The GOG Foundation, Inc.
PRESS RELEASE
Philadelphia, PA, USA, March 26, 2024, The GOG Foundation, Inc. (GOG-F) and GOG Partners enrolls first patient in for GOG 3068: A Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial). The HOTT Trial, an investigator-initiated trial (IIT), supported by GSK, randomized the first patient on trial on Friday, March 8, 2024, by Dr. Charles Dietrich, study PI at the University of Kentucky Markey Cancer Center.
“I am thrilled to extend my gratitude and congratulations to Dr. Charles Dietrich at the University of Kentucky Markey Comprehensive Cancer Center and to his patient, the first enrolled to the landmark HOTT trial, which will measure the effectiveness and side effects of HIPEC when given prior to niraparib maintenance. My additional gratitude goes to the GOG Foundation and our many co-investigators for their steadfast commitment to this important trial,” notes study chair, Leslie Randall, MD, Professor and Director, Division of Gynecologic Oncology at the Massey Comprehensive Cancer Center at Virginia Commonwealth University.
The GOG-F Leadership is proud to have selected this IIT, which might play a vital role in developing potential and life-saving therapies and new techniques to manage ovarian cancer. Dr. Dietrich adds, “Our HIPEC team at the University of Kentucky Markey Comprehensive Cancer Center is excited to participate in the HOTT Trial and appreciate the support of the GOG-F and GSK in making this landmark study an option for ovarian cancer patients across the country. We look forward to offering this trial to future patients and contributing to the study’s objectives.”
Ultimately, all GOG-F trials are about improving the outcomes of our patients, noted a statement by Thomas J. Herzog, MD, GOG-F President, and Gynecologic Oncology, at the University of Cincinnati. Dr. Herzog continues, “Managing this trial within our own community, as a site management organization, and through engagement of the Investigator Council (IC), a committee of high-quality investigators highlights the opportunities we can bring to patients through our collaborative network. This trial is another opportunity to positively impact our patients and help them get tomorrow’s treatments today.”
This trial will enroll 260 patients at 35 sites in the United States.
About GOG-3068, The HOTT Trial (NCT05659381):
HOTT is a prospective, randomized trial of hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin compared to no HIPEC at the time of interval cytoreductive surgery (iCRS) followed by niraparib maintenance in patients with newly diagnosed stage III and IV ovarian, primary peritoneal and fallopian tube cancer. The HOTT trial was designed to determine if the benefit of intraoperative HIPEC that was seen in OVHIPEC-11 is maintained in a contemporary setting where maintenance niraparib is given. HOTT will also evaluate the effect of homologous recombination deficiency (HRD) status on the response to HIPEC and the effect of enhanced recovery after surgery (ERAS) on surgical morbidity. The GOG is receiving support for this investigator-initiated trial from GSK.
About Ovarian Cancer
Ovarian cancer is one of the leading causes of cancer death among women with an estimated 19,680 women receiving a new diagnosis of ovarian cancer and 12,740 women dying from ovarian cancer in 2024.1 A woman's risk of getting ovarian cancer during her lifetime is about 1 in 87. Her lifetime chance of dying from ovarian cancer is about 1 in 130. (These statistics do not include low malignant potential ovarian tumors.). About half of the women who are diagnosed with ovarian cancer are 63 years or older. It is more common in White women than Black women, and risk is increased for carriers of BRCA gene mutations and those with BRCA-like gene mutations.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.
About GOG Partners
Supported by industry, GOG Partners is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.
- van Driel et. al, N Engl J Med 2018; 378:230-240
- https://www.cancer.org/cancer/types/ovarian-cancer/about/key-statistics.html, accessed 3.21.2024
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Corporate & Media Contact:
GOG Partners
Jenna Cummins, CMP, Executive Director of Business Development
773-750-5753, jcummins@gog.org
Method of Research
Randomized controlled/clinical trial
Subject of Research
People