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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Baptist Health South Florida | OTHER |
| Hartford HealthCare | OTHER |
| University of Pittsburgh |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondary Cytoreductive Surgery with HIPEC | Experimental | secondary 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 | Experimental | secondary 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secondary Cytoreductive Surgery | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the toxicity and postoperative complications rate | The safety endpoint of our trial is to determine toxicity and postoperative complication rates in both arms using NCI Common Terminology Criteria for Adverse Events version 4.0. and MSKCC Surgical Secondary Events Grading System for complications. | 4 weeks post op |
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Inclusion Criteria:
Inclusion Criteria for Eligibility Prior to Surgery:
Inclusion Criteria for Eligibility Post-Surgery:
Exclusion Criteria:
Exclusion Criteria for Eligibility Prior to Surgery:
Exclusion Criteria for Eligibility Post-Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Chi, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34019431 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| OTHER |
| University of Chicago | OTHER |
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| Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) |
| Drug |
|
| platinum-based systemic chemotherapy postoperatively | Drug | 5 cycles |
|
| platinum-based systemic chemotherapy postoperatively | Drug | 6 cycles |
|
| determine the completion rate of four cycles |
A 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. |
| 5 years |
| pharmacokinetics | in 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. | 5 years |
| 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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