AzTrials
AzTrials

Stage III Ovarian CancerPhase 3HOTTNCT05659381

Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

A Phase 3 study testing Cisplatin and No treatment in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by GOG Foundation at 59 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cisplatin and No treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
59 sitesUnited States
Study dates
8 Mar 2024to 1 Aug 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a pathologic diagnosis of high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, FIGO stage III or IV documented on CT scan/MRI, must be recommended and agree to undergo platinum-based neoadjuvant chemotherapy with or without physician choice bevacizumab (3-4 cycles allowed, with bevacizumab held for at least 28 days preoperatively) and are considered candidates for (and planned to have) interval cytoreductive surgery (iCRS) followed by chemotherapy and niraparib maintenance as determined by the enrolling investigator. Patients may continue bevacizumab after a minimum of 28 days post iCRS and during niraparib maintenance per local standard.
  • Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) or be deemed resectable with iCRS.
  • Patients must have HRD/LOH positive tumors. Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not required to have HRD/LOH testing. Patients without BRCA or germline mutations must have HRD/LOH testing using Myriad myChoice®/Foundation Medicine/Caris Life Sciences platforms. HRD test results must be available prior to registration to meet entry criteria.
  • Patients must have R0 (no gross/visible residual disease) or R1 (gross/visible residual disease ≤ 1.0 cm in the longest diameter) following iCRS and prior to randomization.
  • Patient must have adequate bone marrow and organ function:
  • Bone marrow function:
Show all 27Show fewer
  • Hemoglobin ≥ 8.5 g/dL. Absolute neutrophil count (ANC) ≥ 1,500/mm3. Platelets ≥ 100,000/mm3.
  • Renal function:
  • Creatinine ≤ 1.3mg/dl OR Calculated creatinine clearance (≥ 30 mL/min/1.73 m2) per National Kidney Foundation guidelines and NHANES III
  • Hepatic function:
  • Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN.
  • Neurologic function:
  • Peripheral neuropathy ≤ CTC AE grade 2.
  • Patients must have an ECOG performance status of 0 or 1.
  • Patient must be age > 18.
  • Patients must have a life expectancy > 3 months.
  • Patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to iCRS and must be practicing an effective form of contraception (with failure rate <1% per year) during the study period and for 6 months following the last dose of niraparib. Patients of childbearing potential must consent to pregnancy testing prior to receiving niraparib and monthly thereafter for the duration of the study.
  • Patients are considered postmenopausal and not of child-bearing potential if they are free from menses for >1 year or surgically sterilized.
  • Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension based on local standard of care (systolic BP ≤ 140 mmHg and diastolic ≤ 90 mmHg) prior to starting niraparib.
  • Patients receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to randomization.
  • Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:
  • Cluster of differentiation 4 ≥350/µL and viral load <400 copies/mL
  • No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment
  • No history of HIV associated malignancy for the past 5 years
  • Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started >4 weeks prior to study enrollment
  • Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.

Who cannot join

  • Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors.
  • Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy. Prior neoadjuvant treatment with bevacizumab is allowed; bevacizumab must be held for 28 days prior to surgery.
  • Patients whose tumors are HRD/LOH negative.
  • Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan/MRI required within 35 days of iCRS).
  • Patients not eligible for iCRS based on medical co-morbidities as per the enrolling investigator.
  • Patients with stage IV disease without complete response of extra-abdominal disease on preoperative findings (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, mesemchymal liver metastases or other extra-abdominal metastases) who are not deemed resectable with iCRS.
Show all 23Show fewer
  • Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.
  • Patients who are pregnant or lactating.
  • Patients with a severe infection requiring IV antibiotics within 2 weeks of planned randomization.
  • Patients with other uncontrolled, intercurrent medical conditions.
  • Patient with metastatic disease to the central nervous system.
  • Patient with uncontrolled insulin dependent diabetes or pre-existing renal condition.
  • Patients with pre-existing hearing loss related to prior platinum-based chemotherapy.
  • Patients with Prior Reversible Encephalopathy Syndrome (PRES).
  • Patients with current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). Severe hepatic impairment patients should be excluded.
  • Patients with any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels that is not related to ovarian cancer.
  • Patients with clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months to randomization, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months).
  • Patients with an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to study randomization and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
  • Patients with known active hepatitis B (eg, hepatitis B surface antigen reactive) are excluded unless their HBV is stably controlled on nucleos(t)ide analogs (eg entecavir or tenofovir) which will be continued for the duration of the study.
  • Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study randomization.
  • Patient has received a live vaccine within 30 days of study randomization. COVID-19 vaccines that do not contain live viruses are allowed at any time during the study.
  • Patient has a diagnosis, detection, or treatment of another type of invasive cancer ≤ 2 years prior to initiating protocol therapy (except for basal or squamous cell carcinoma of the skin, cervical cancer in situ, and ductal cancer in situ (DCIS) that has been definitively treated).
  • Patients must not have had radiotherapy encompassing > 20% of the bone marrow within 2 weeks of randomization; or any radiation therapy within 1 week prior to randomization.

Trial locations and contacts

59 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sarin Chhab contact

215-854-0770

schhab@gog.org

Shanon Matkin contact

801-661-1584

smatkin@gog.org

59 sites in 1 country

United States59 sites, 59 recruiting

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

    Lea Moukarzel, MD

    Recruiting

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87102

    Rebecca Baca, 505-272-4946, ReBaca@salud.unm.edu

    Carolyn Muller, MD

    Recruiting

  • University of Colorado Hospital - Anshutz Cancer Pavilion

    Aurora, Colorado, 80045

    Lindsay J Wheeler Brubaker, MD

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78758

    Helen Eshed, MD

    Recruiting

  • UH Geauga Medical Center

    Chardon, Ohio, 44024

    Lauren Patrick, lauren.patrick@UHHospitals.org

    Sarah Lynam, MD

    Recruiting

  • Medical University of South Carolina (Hollings Cancer Center)

    Charleston, South Carolina, 29425

    Carly Fecio, fecio@musc.edu

    Brian Orr, orrb@musc.edu

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Caroline Billingsley, MD, billincn@ucmail.uc.edu

    Caroline Billingsley, MD

    Recruiting

  • TriHealth Cancer Institute - Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Patrick Newbury, patrick_newbury@trihealth.com

    Robert Neff, MD

    Recruiting

  • TriHealth Cancer Institute- Thomas Comprehensive Care Center

    Cincinnati, Ohio, 45242

    Patrick Newbury, Patrick_Newbury@trihealth.com

    Robert Neff, MD

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Lauren Patrick, lauren.patrick@UHHospitals.org

    Sarah Lynam, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Jacqueline Ludwig, ludwigj@ccf.org

    Robert Debernardo Jr., MD

    Recruiting

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

    Smita Bhukan, sxb9533@med.miami.edu

    Patricia Rozas, px445@med.miami.edu

    Recruiting

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida, 33442

    Smita Bhukan, sxb9533@med.miami.edu

    Patricia Rozas, px445@med.miami.edu

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Hesham Mahmoud, hmahmoud@coh.org

    Thanh Dellinger, MD

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Karen Grace, karen.grace@duke.edu

    Jennifer L McNally, MD

    Recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Adela Mahmutovic, adela.mahmutovic@inova.org

    Leslie Randall, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Amy Brown, MD, amy.brown@hhchealth.org

    Amy Brown, MD

    Recruiting

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

    Carolyn Thibodeaux, carolynt@bcm.edu

    Anthony Costales, MD

    Recruiting

  • O'Quinn Medical Tower at McNair Campus

    Houston, Texas, 77054

    Carolyn Thibodeaux, carolynt@bcm.edu

    Anthony Costales, MD

    Recruiting

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Siobhan Guyach, Siobhan.guyach@ahn.org

    John Nakayama, MD

    Recruiting

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of Kansas Medical Center MOB

    Kansas City, Kansas, 66160

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Missouri, 64116

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of Kansas Cancer Center North

    Kansas City, Missouri, 64154

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92037

    Alexandrea Cronin, aocronin@health.ucsd.edu

    Michael McHale, MD

    Recruiting

  • University of Kansas Cancer Center Lee's Summit

    Lee's Summit, Missouri, 64064

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

    Ashley Walton-Robbins, Ashley.Walton-Robbins@uky.edu

    Aneesha Carter, aneesha.carter@uky.edu

    Recruiting

  • SCC at Lake University

    Mentor, Ohio, 44060

    Lauren Patrick, lauren.patrick@UHHospitals.org

    Sarah Lynam, MD

    Recruiting

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

    Smita Bhukan, sxb9533@med.miami.edu

    Patricia Rozas, px445@med.miami.edu

    Recruiting

  • Miami Cancer Institute

    Miami, Florida, 33176

    Jacqueline Lebron, jacquelile@baptisthealth.net

    John Diaz, MD

    Recruiting

  • Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Subarna Paul, supaul@mcw.edu

    Denise Uyar, MD

    Recruiting

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

    Siobhan Guyach, Siobhan.guyach@ahn.org

    John Nakayama, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Krista Garbacz, krista.garbacz@vumc.org

    Marta Crispens, MD

    Recruiting

  • Smilow Cancer Hospital at Yale- New Haven

    New Haven, Connecticut, 06511

    Lisa Baker

    Vaagn Andikyan, MD

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

    Lisa Baker, lisa.baker@yale.edu

    Elena Ratner, MD

    Recruiting

  • LSU Health New Orleans

    New Orleans, Louisiana, 70112

    Carla Laborde, cscion@lsuhsc.edu

    Amelia Jernigan, MD

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Eileen Mederos, emede1@lsuhsc.edu

    Amelia Jernigan, MD

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10022

    Bhavani Ramesh, rameshb@mskcc.org

    Dennis Chi, MD

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Atessa Kiani, atessa.kiani@hoag.org

    Alberto Mendivil, MD

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Jenny Marks, jenny.marks@usoncology.com

    Danielle Chau, MD

    Recruiting

  • UH Minoff Health Center at Chagrin Highlands

    Orange, Ohio, 44122

    Lauren Patrick, lauren.patrick@UHHospitals.org

    Sarah Lynam, MD

    Recruiting

  • University of Kansas Cancer Center Overland Park

    Overland Park, Kansas, 66210

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of Kansas Indian Creek Breast Surgery

    Overland Park, Kansas, 66211

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • Stanford Ambulatory Surgery Center Lane Operating Room

    Palo Alto, California, 94034

    Amer Karam, MD

    Recruiting

  • Stanford Women's Cancer Center

    Palo Alto, California, 94304

    Amer Karam, MD

    Recruiting

  • Stanford Hospital

    Palo Alto, California, 94305

    Amer Karam, MD

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Siobhan Guyach, Siobhan.guyach@ahn.org

    John Nakayama, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center - Plantation

    Plantation, Florida, 33324

    Smita Bhukan, sxb9533@med.miami.edu

    Patricia Rozas, px445@med.miami.edu

    Recruiting

  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27607

    Jennifer L McNally, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Carrie Langstraat, MD, langstraat.carrie@mayo.edu

    Carrie Langstraat, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Tiara Redrick, tredrick@wustl.edu

    Premal Thaker, MD

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

    Marissa Van Orden, mvanorden@holyname.org

    Sharyn Lewin

    Recruiting

  • West Chester Hospital

    West Chester, Ohio, 45069

    Caroline Billingsley, billincn@ucmail.uc.edu

    Caroline Billingsley, MD

    Recruiting

  • St. John Medical Center

    Westlake, Ohio, 44145

    Lauren Patrick, lauren.patrick@UHHospitals.org

    Sarah Lynam, MD

    Recruiting

  • University of Kansas Cancer Center Westwood

    Westwood, Kansas, 66205

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • University of Kansas Clinical Research Center

    Westwood, Kansas, 66205

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Andrea Jewell, MD

    Recruiting

  • Wexford Hospital

    Wexford, Pennsylvania, 15090

    Siobhan Guyach, Siobhan.guyach@ahn.org

    John Nakayama, MD

    Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

    Lea Moukarzel, MD

    Recruiting

  • Lankenau Medical Center/Mainline Medical Center

    Wynnewood, Pennsylvania, 19096

    Jessica Burrell, BurrellJe@mlhs.org

    David Holtz, holtzD@mlhs.org

    Recruiting

Other trials in United States

About this study

Official title: GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Homologous Recombinant Deficient (HRD +) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.

Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery.

Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).

Being tested
Cisplatin, No treatment
Keywords
HIPEC
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Platinol AQ

    Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius

  • No treatmentOther

    No treatment with Cisplatin

Study groups in NCT05659381
Study groupRoleWhat they receive
HIPECExperimentalHyperthermic Intraperitoneal Chemotherapy (HIPEC) Cisplatin 100 mg/m2 IP over 90 minutes at 42 degrees C
Receives: Drug: Cisplatin
No HIPECActive comparatorNo treatment
Receives: Other: No treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Progression free survival in patients who receive a single treatment of intraoperative HIPEC with cisplatin vs. those who do not receive intraoperative HIPEC with cisplatin.

    Measured: From enrollment until time of disease progression or death, whichever occurs first, or date of last contact if neither progression of death has occurred, assessed up to 8 years

Secondary outcomes (3)

  1. Overall Survival

    Overall survival stratified by:

    1. Stage at diagnosis (stage III vs. stage IV)
    2. Germline or somatic mutation (yes vs. no)
    3. Physician choice bevacizumab (yes vs. no)
    4. Residual disease (no gross/visible residual disease vs. gross/visible residual disease less than or equal to 1 cm in longest diameter

    Measured: From enrollment to the time of death or date of last contact, assessed up to 8 years

  2. Frequency and severity of adverse events

    The frequency and severity of adverse events as defined by CTCAE version 5.0

    Measured: Every 28 days up to 3 years

  3. Progression Free Survival

    Progression Free Survival stratified by:

    1. Stage at diagnosis (stage III vs. stage IV)
    2. Germline or somatic mutation (yes vs. no)
    3. Physician choice bevacizumab (yes vs. no)
    4. Residual disease (no gross/visible residual disease vs. gross/visible residual disease less than or equal to 1 cm in longest diameter

    Measured: From the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start8 Mar 2024
  3. Primary completion1 Aug 2029 (estimated)
  4. Study completion1 Aug 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659381
Sponsor's protocol ID
GOG-3068
Other IDs
217908
Acronym
HOTT
Status last verified
Dec 2025
First submitted
5 Dec 2022
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin and No treatment in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by GOG Foundation at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarin Chhab (215-854-0770, schhab@gog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From enrollment until time of disease progression or death, whichever occurs first, or date of last contact if neither progression of death has occurred, assessed up to 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05659381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in