Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer

This is a phase I prospective study with the primary objective to compare the efficacy and
safety of CRS and HIPEC. The target population for this study is patients with ovarian,
primary peritoneal or fallopian tube cancers undergoing secondary CRS after the first
platinum-sensitive recurrence. 'Platinum-sensitive' recurrence is defined as recurrence 6
months after the completion of the primary platinum-based chemotherapy. Carboplatin,
delivered as HIPEC, will be administered at the time of surgery. Subjects will receive a
single cycle of hyperthermic intraperitoneal chemotherapy. Patients will then go on to
receive standard platinum-based combination doublet chemotherapy (carboplatin and paclitaxel,
carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles.

Eligible patients consenting to this protocol will undergo their scheduled surgical
procedure. After surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of
carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal
hyperthermic perfusion using the closed-abdomen technique (43). HIPEC will be continued for
90 minutes in the hyperthermic phase (41°C-43°C). At 4-6 weeks after CRS, patients will go on
to receive 6 cycles of standard IV platinum-based chemotherapy. Surveillance CT Chest,
abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 6,
9, 12 and 18 months after the day of surgery. Recurrence-free survival will be assessed using
RECIST 1.1 guideline (version 1.1).

Inclusion Criteria:

- Age > 21 years old • Patients with diagnosis of epithelial ovarian carcinoma, primary
peritoneal carcinoma, or fallopian tube carcinoma that has recurred >6 months since
platinum-based chemotherapy (first recurrence) and are scheduled for secondary
surgical evaluation/cytoreduction • ECOG/WHO Performance score of 0 to 1

- Histologic types feature would be serous, endometrioid, clear cell, undifferentiated
carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma • No End organ
function

- Patients must have less than or equal to 2.5 mm residual disease at the completion of
the secondary surgery to be eligible for the study

Exclusion Criteria:

- Subjects who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded • Subjects with invasive malignancies or had any evidence of
the other cancer present within the last 3 years

- Tumors of low malignant potential • Patients with active coronary artery disease •
Patients with known acute hepatitis • Patients with restrictive or obstructive
pulmonary disease

- Patient with extra-abdominal metastatic disease • Immuno-compromized patients

- Known carboplatin or Cisplatin allergy • Life expectancy < 3 months