Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

Not Applicable

• Conditions: Ovarian Cancer Recurrent
• Interventions: Procedure: radical surgery with HIPEC

• Registration Number: NCT03717610
• Lead Sponsor: Uppsala University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min	radical surgery with HIPEC	-

Primary Outcome Measures

Name	Time	Method
Treatment-related toxicities	3 months after surgery	Registration of the effects according to NCI CTCAEv4.0 guidelines.

Secondary Outcome Measures

Name	Time	Method
Assessment of quality of Life in relation to eventually performed intestinal surgery	before surgery, and 4 weeks, 3 months and 6 months after surgery	EORTC CR29 quality of life questionnaire
Assessment of quality of life	before surgery, and 4 weeks, 3 months and 6 months after surgery	EORTC C30 quality of life questionnaire
Morbidity	30 days after surgery	Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale
Assessment of quality of life in relation to ovarian cancer	before surgery, and 4 weeks, 3 months and 6 months after surgery	EORTC OV28 quality of life questionnaire
Mortality	90 days after surgery	Number of participants with lethal outcome

Trial Locations

Locations (1)

Uppsala University Hopsital; 🇸🇪 Uppsala, Sweden