NCT01767675

Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Randomized Study: Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer. The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary peritoneal cancer.

Conditions

• Ovarian Cancer
• Fallopian Tubes Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
PROCEDURE	Secondary Cytoreductive Surgery
DRUG	Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
DRUG	platinum-based systemic chemotherapy postoperatively	5 cycles
DRUG	platinum-based systemic chemotherapy postoperatively	6 cycles

Timeline

• Start date: 2013-01-08
• Primary completion: 2025-08-26
• Completion: 2025-08-26
• First posted: 2013-01-14
• Last updated: 2025-08-27

Locations

11 sites across 1 country: United States