HIPEC + Surgery for Ovarian Cancer
(CRS/HIPEC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byArmando Sardi, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mercy Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Eligibility Criteria

This trial is for adults with advanced stage (III/IV) ovarian, fallopian tube, or primary peritoneal cancer who haven't had treatment yet. They should be physically able to handle the procedures and have good organ function. Pregnant women, those with certain heart conditions, prior strokes or other cancers in the last 3 years are excluded.

Inclusion Criteria

My condition is in stage III or IV.

I haven't had treatment or major surgery for ovarian, fallopian tube, or peritoneal cancer, but diagnostic laparoscopy is okay.

My health allows me to receive chemotherapy after surgery.

+8 more

Exclusion Criteria

I am currently on IV antibiotics for an infection.

I had a heart attack or other heart issue in the last 6 months.

I have moderate to severe heart failure.

+12 more

Participant Groups

The study tests how safe and effective it is to combine cytoreductive surgery (CRS) with heated chemotherapy directly in the abdomen (HIPEC), followed by standard chemo. It's a phase II trial where patients are randomly assigned to treatments at a community hospital.

2Treatment groups

Experimental Treatment

Active Control

Group I: CRS/HIPEC with adjuvant IV chemotherapyExperimental Treatment6 Interventions

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up

Group II: CRS with adjuvant IV/IP chemotherapyActive Control5 Interventions

Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: