NCT05659381 · GOG Foundation
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
(HOTT)
What this study is about
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV 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.
View original scientific description
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV 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.
Interventions
DRUG
Cisplatin
Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius
OTHER
No treatment
No treatment with Cisplatin
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have a pathologic diagnosis of high grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage III or IV documented on CT scan/MRI, must be recommended to undergo neoadjuvant chemotherapy (3-4 cycles allowed) and are considered candidates for interval cytoreductive surgery (iCRS) as determined by the enrolling investigator. 2. 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). 3. Patient must have no gross residual disease or no disease \>1.0 cm in largest diameter following iCRS and prior to randomization. 4. Patients must have Myriad myChoice HRD test results available prior to registration. 5. Patient must have adequate bone marrow and organ function: Bone marrow function: Hemoglobin ≥ 8.5 g/dL. Absolute neutrophil coun
Where
- Duarte, California
- La Jolla, California
- Newport Beach, California
- Palo Alto, California
- Aurora, Colorado
- Hartford, Connecticut
- New Haven, Connecticut
- Coral Gables, Florida
- Deerfield Beach, Florida
- Miami, Florida
- Plantation, Florida
- Kansas City, Kansas
And 34 more locations — see the full list below.
Collaborators
GlaxoSmithKline
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations