HIPEC After Initial CRS in Patients Who Have Received NACT
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
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.