Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

Uppsala University Hospital

Status

Unknown

Conditions

Ovarian Cancer Recurrent

Treatments

Procedure: radical surgery with HIPEC

Study type

Interventional

Funder types

Other

Identifiers

NCT03717610

077/2018

Details and patient eligibility

About

This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.

Full description

Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A "one-time" hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC.

Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.

Enrollment

10 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients with diagnosis of recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma after 6 month since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction
ECOG/WHO Performance score of 0 to 1
Adequate respiratory, hepatic, cardiac, kidney and bone marrow function ( Hb >= 8 g/dl, absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, creatinine clearance > 60 mL/min according to Cockroft formula)
Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
Histological 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 cytoreductive surgery to be eligible for the study
Patient-compliant and psychologically able to follow the trial procedures, signature of informed consent.

Exclusion criteria

Evidence of extensive retroperitoneal lymph node disease
Neuropsychiatric disorders;
Pregnancy or breast feeding.
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. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease
Subjects with active infection that requires parenteral antibiotics
Tumors of low malignant potential, or non-invasive borderline tumors
Patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions, chronic or latent infectious diseases, immune deficiency, or history, which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study
Patient with extra-abdominal metastatic disease
Known platinum (carboplatin or cisplatin) allergy
Life expectancy < 3 months
Still, it will not be considered for the HIPEC protocol those patients with unresectable disease (presence of invasive peritoneal implants inoperable or at high risk for resection in critical locations such as hepatic hilum, the mesenteric root, trunk celiac, mesentery, and several small implants the serosa of the small intestine) and / or with residual disease after cytoreduction greater than or equal to 2.5 mm (CC-2 and CC-3).