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
1 other identifier
interventional
99
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started Jan 2013
Longer than P75 for phase_2 ovarian-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2013
CompletedFirst Submitted
Initial submission to the registry
January 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2025
CompletedAugust 27, 2025
August 1, 2025
12.6 years
January 10, 2013
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
determine the proportion of patients who are without evidence of disease progression
A 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.
24 months
Secondary Outcomes (3)
To determine the toxicity and postoperative complications rate
4 weeks post op
determine the completion rate of four cycles
5 years
pharmacokinetics
5 years
Study Arms (2)
Secondary Cytoreductive Surgery with HIPEC
EXPERIMENTALsecondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B). In some patients randomized to HIPEC at MSKCC only , peritoneal fluid and blood samples will be drawn before, during and after the HIPEC procedure.
Secondary Cytoreductive Surgery without HIPEC
EXPERIMENTALsecondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B).
Interventions
5 cycles
Eligibility Criteria
You may qualify if:
- 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:
- +9 more criteria
You may not qualify if:
- Tumors of low malignant potential (borderline carcinomas).
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded.
- Patients with a history of primary endometrial cancer are excluded unless the following conditions are met:
- Stage not greater than IA.
- Not a poorly differentiated subtype (including papillary serous, clear cell or other FIGO grade 3 lesions)
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies, who had any evidence of the other cancer present within the last 1 year or whose previous cancer treatment contraindicates this protocol therapy, are excluded.
- Subjects with known active acute hepatitis.
- Subjects with active infection that requires parenteral antibiotics.
- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
- Patients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment.
- Uncontrolled hypertension defined as \> 140/90 and not cleared for surgery at the time of consent..
- New York Heart Association (NYHA) Class II or higher Congestive heart failure.
- History of cerebrovascular disease.
- Immune deficiency: Clinically significant primary or acquired immune deficiency (i.e. AIDS or on immunosuppressive medication after organ transplant).
- Patients with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Mayo Cliniccollaborator
- Baptist Health South Floridacollaborator
- Hartford HealthCarecollaborator
- University of Pittsburghcollaborator
- University of Chicagocollaborator
Study Sites (11)
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102, United States
Baptist Health South Florida
Miami, Florida, 33143, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities, except surgery)
Uniondale, New York, 11553, United States
Related Publications (1)
Zivanovic O, Chi DS, Zhou Q, Iasonos A, Konner JA, Makker V, Grisham RN, Brown AK, Nerenstone S, Diaz JP, Schroeder ED, Langstraat CL, Paroder V, Lakhman Y, Soldan K, Su K, Gardner GJ, Andikyan V, Guo J, Jewell EL, Long Roche K, Troso-Sandoval T, Lichtman SM, Moukarzel LA, Dessources K, Abu-Rustum NR, Aghajanian C, Tew WP, Beumer J, Sonoda Y, O'Cearbhaill RE. Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study. J Clin Oncol. 2021 Aug 10;39(23):2594-2604. doi: 10.1200/JCO.21.00605. Epub 2021 May 21.
PMID: 34019431DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Chi, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2013
First Posted
January 14, 2013
Study Start
January 8, 2013
Primary Completion
August 26, 2025
Study Completion
August 26, 2025
Last Updated
August 27, 2025
Record last verified: 2025-08