HIPEC After Initial CRS in Patients Who Have Received NACT
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|ClinicalTrials.gov Identifier: NCT03540017|
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : March 11, 2020
The majority of women diagnosed with ovarian, fallopian tube and primary peritoneal cancer present with advanced stage III and IV disease. Despite aggressive surgery and systemic chemotherapy, the majority of patients will relapse. Five year survival remains only 20-35% for patients diagnosed with bulky stage IIIC and IV cancers. Patients who are not candidates for an initial cytoreductive surgery at the time of diagnosis form a particularly poor prognosis group. These patients are treated with neoadjuvant chemotherapy (NACT) and will ultimately undergo cytoreductive surgery provided there is a response to chemotherapy. New therapies for this cohort of women are urgently needed.
The investigators have designed a pilot study to evaluate the feasibility of heated intraoperative peritoneal chemotherapy (HIPEC) given at the time of interval cytoreductive surgery after 3 cycles of NACT. Patients undergoing NACT for ovarian, fallopian tube or primary peritoneal cancer will be evaluated after their third cycle of chemotherapy for trial participation. Patient meeting eligibility criteria will proceed with cytoreductive surgery. HIPEC will be administered in those patients in whom optimal tumor cytoreduction is achieved. Primary objective of this study is to evaluate the feasibility, toxicity and tolerability of HIPEC administered after NACT.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma||Drug: Cisplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Heated Intraperitoneal Chemotherapy (HIPEC) After Interval Cytoreductive Surgery (CRS) in Patients Who Have Received Neoadjuvant Chemotherapy (NACT) for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers|
|Actual Study Start Date :||March 12, 2019|
|Estimated Primary Completion Date :||July 5, 2020|
|Estimated Study Completion Date :||July 1, 2024|
Patient will receive HIPEC in the form of Cisplatin 100mg/m2. 5. HIPEC will be provided at completion of surgical cytoreduction. The chemotherapy will be ordered by the treating gynecologic oncologist. It will be prepared in the chemotherapy pharmacy and delivered to the operating room once the surgeon confirms optimal cytoreduction and eligibility. Patients undergoing bowel resection will be left with bowel in discontinuity during the HIPEC infusion cycle. The abdomen will be temporarily closed with skin staples to prevent spillage of the perfusate. HIPEC will be delivered using the closed technique as has been well described.
Heated Intraperitoneal Chemotherapy will be administered after the completion of interval cytoreductive surgery after three cycles of neoadjuvant chemotherapy.
- Morbidity, assessed by the occurrence of adverse events and serious adverse events [ Time Frame: 30 days ]Severity of adverse events will be evaluated using the NCI Common Terminology Criteria for Adverse Events version 4.0 [NCI CTCAE v4.0]. AEs will be classified as possibly, probably, or definitely related to study treatment.
- Safety data obtained from scheduled exams [ Time Frame: 1 year ]Physical examinations, vital signs, hematologic and clinical parameters, measured monthly for 12 months after initial study treatment or subject discontinuation, whichever comes first.
- Mortality [ Time Frame: 5 years ]Time from surgery date to death due to any cause.
- Progression-free survival [ Time Frame: 5 years ]Time from surgery date to the first documentation of disease progression or death due to any cause.
- Ability to complete systemic IV chemotherapy after IDS and HIPEC [ Time Frame: 1 year ]Patient completion of systemic IV chemotherapy after surgery and HIPEC.
- Functional Assessment of Cancer Therapy-Ovarian (FACT-O) [ Time Frame: 2 years ]Survey administered to assess for quality of life.
- Completeness of surgical cytoreduction [ Time Frame: 24 hours ]Complete cytoreduction will be determined as having a CC score of 0 or 1
- Achievement of hyperthermia [ Time Frame: 24 hours ]Target intra-peritoneal temperature of 41-43°C.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540017
|Contact: Jill S Whyte, MDfirstname.lastname@example.org|
|Contact: Aaron Nizam, MDemail@example.com|
|United States, New York|
|Long Island Jewish Medical Center||Recruiting|
|New Hyde Park, New York, United States, 11040|
|Contact: Jill Whyte, MD 516-562-4438 firstname.lastname@example.org|
|Principal Investigator:||Jill Whyte, MD||Northwell Health|