Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05659381 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer, sponsored by GOG Foundation.

Recruiting
Registry status
Phase 3
Development phase
220
Enrollment target
20
Study locations

NCT05659381 is a Phase 3 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer that is actively recruiting participants, run by GOG Foundation. The registered enrollment target is 220 participants, above the 54-participant average among 5 other Stage IV Ovarian Cancer trials with a reported enrollment target (307% higher). The trial reports 20 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05659381, a Phase 3 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer, is actively recruiting participants, sponsored by GOG Foundation.

RECRUITING
Registry status
Phase 3
Development phase
220 participants
Enrollment target
20
Study locations

Study 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. 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).

Conditions Studied

Stage IV Ovarian Cancer Stage III Ovarian Cancer Stage III Primary Peritoneal Cancer Stage IV Primary Peritoneal Cancer Stage III Fallopian Tube Cancer Stage IV Fallopian Tube Cancer

Interventions

  • DRUG Cisplatin
  • OTHER No treatment

Study Locations (20)

California

  • City of Hope - Duarte
  • University of California San Diego Moores Cancer Center - La Jolla
  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Stanford Ambulatory Surgery Center Lane Operating Room - Palo Alto
  • Stanford Women's Cancer Center - Palo Alto
  • Stanford Hospital - Palo Alto

Kansas

  • University of Kansas Hospital - Kansas City
  • University of Kansas Medical Center MOB - Kansas City
  • University of Kansas Cancer Center Overland Park - Overland Park
  • University of Kansas Indian Creek Breast Surgery - Overland Park
  • University of Kansas Cancer Center Westwood - Westwood
  • University of Kansas Clinical Research Center - Westwood

Florida

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center - Coral Gables
  • University of Miami Hospital and Clinics - Deerfield Beach - Deerfield Beach
  • University of Miami Hospital and Clinics - Miami
  • Miami Cancer Institute - Miami
  • Sylvester Comprehensive Cancer Center - Plantation - Plantation

Connecticut

  • Smilow Cancer Hospital at Yale- New Haven - New Haven
  • Yale University School of Medicine - New Haven

Colorado

  • University of Colorado Hospital - Anshutz Cancer Pavilion - Aurora

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2024-03-08
Est. Completion 2034-08-01
Phase Phase 3

Sponsor

GOG Foundation

14 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05659381

The ClinicalTrials.gov registry entry for NCT05659381 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 54-participant average among 5 other Stage IV Ovarian Cancer trials with a reported enrollment target (307% higher). The listed sponsor is GOG Foundation, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Stage IV Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cisplatin is the first listed.

NCT05659381 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Kansas, Florida.

Frequently Asked Questions

What is clinical trial NCT05659381 about?

NCT05659381 is a clinical study titled "Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer". 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 ...

What is the current status of trial NCT05659381?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2024-03-08. Estimated completion is 2034-08-01.

What conditions does trial NCT05659381 study?

This clinical trial studies the following conditions: Stage IV Ovarian Cancer, Stage III Ovarian Cancer, Stage III Primary Peritoneal Cancer, Stage IV Primary Peritoneal Cancer, Stage III Fallopian Tube Cancer.

What interventions are being tested in trial NCT05659381?

The interventions under investigation include: Cisplatin (DRUG), No treatment (OTHER).

Who is sponsoring clinical trial NCT05659381?

This trial is sponsored by GOG Foundation, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05659381 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV Ovarian Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Stage IV Ovarian Cancer

All registered trials for this condition

Stage III Ovarian Cancer

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.