Skip to content

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01767675
Enrollment
99
Registered
2013-01-14
Start date
2013-01-08
Completion date
2025-08-26
Last updated
2026-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Fallopian Tubes Cancer, Peritoneal Cancer

Keywords

Secondary Cytoreductive Surgery, Carboplatin, Hyperthermic Intraperitoneal Chemotherapy (HIPEC), 12-275

Brief 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.

Interventions

DRUGCarboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
DRUGplatinum-based systemic chemotherapy postoperatively

5 cycles

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
Mayo Clinic
CollaboratorOTHER
Baptist Health South Florida
CollaboratorOTHER
Hartford HealthCare
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
University of Chicago
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria for Eligibility Prior to Surgery: * Age ≥ 21 years old. * Patients with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred \>6 months since platinum-based chemotherapy (first recurrence) and who are scheduled for secondary surgical evaluation/cytoreduction. * Histologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma N.O.S. * Karnofsky Performance Status (KPS) of ≥ 70%. * Disease-free interval ≤ 30 months. * No prior chemotherapy in the recurrent setting. Prior hormonal therapy is permitted. Concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase inhibitors etc.) is not allowed for patients participating in study treatment. Low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given. * Patients receiving maintenance biologic therapy are eligible, provided their recurrence is documented more than 6 months from completion of primary cytotoxic chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed since their last infusion of biologic therapy at the start of protocol intervention, day 1. * Patients must be, after evaluation by the investigator, appropriate candidates for the administration of 5 to 6 cycles of standard platinum-based combination chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, or carboplatin and gemcitabine) following CRS with or without HIPEC. * Bone marrow function: * Hemoglobin ≥ 8.5 g/dL. * Absolute neutrophil count (ANC) ≥ 1,000/mm3. * Platelets ≥ 100,000/mm3. * Renal function: * Creatinine ≤ 1.5mg/dl * 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. * Blood coagulation parameters: * PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT \<1.2 times the ULN. * Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to CRS and must be practicing an effective form of contraception during the study period. Inclusion Criteria for Eligibility Post-Surgery: * Patients will be consented prior to the surgical evaluation/cytoreductive surgery. Patients must have less than or equal to 0.5cm residual disease at the completion of the secondary surgery to be eligible for the study.

Design outcomes

Primary

MeasureTime frameDescription
Progression Free Survivalup to 4 yearsA proportion of patients ≥ 40%, who are without evidence of disease progression at 24 months, is considered acceptable, whereas a proportion of ≤ 25% is considered not acceptable in this patient population.

Secondary

MeasureTime frameDescription
Number of Participants Evaluated for Toxicity4 weeks post opStudy participants will be evaluated for toxicity with the NCI Common Terminology Criteria for Adverse Events version 4.0. and MSKCC Surgical Secondary Events Grading System for complications.
Determine the Completion Rate of Four Cycles5 yearsA secondary analysis of estimating the completion rate will be conducted. The completion rate and a 95% confidence interval will be calculated for each arm separately. Completion is defined as patients being able to complete ≥ 4 out of 5 or 6 cycles of a standard systemic chemotherapy.
Pharmacokinetics for HIPEC Arm Only5 yearsin a subset of patients randomized to receive HIPEC in the OR. In patients randomized to HIPEC, peritoneal fluid and blood samples only from MSKCC patients will be drawn before, during and after the HIPEC procedure.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDennis Chi, MD

Memorial Sloan Kettering Cancer Center

Baseline characteristics

Characteristic—
Age, Continuous58 years
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
87 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
84 Participants
Region of Enrollment
United States
99 Participants
Sex: Female, Male
Female
99 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
20 / 4921 / 50
other
Total, other adverse events
17 / 4919 / 50
serious
Total, serious adverse events
17 / 497 / 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 3, 2026