Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer Recurrent
• Intervention / Treatment: Procedure: radical surgery with HIPEC

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Lomnytska, MD, PhD; Phone Number: +46 018-611 00 00; Email: marta.lomnytska@akademiska.se

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Recruiting
    • Uppsala University Hopsital
    • Contact: Marta Lomnytska, PhD; Phone Number: +46 018-611 00 00; Email: marta.lomnytska@akademiska.se
    • Contact: Ilvars Silins, PhD; Phone Number: +46 018-611 00 00; Email: ilvars.silins@akademiska.se
    • Sub-Investigator: Wilhelm Graf, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min	Procedure: radical surgery with HIPEC; Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related toxicities	Registration of the effects according to NCI CTCAEv4.0 guidelines.	3 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Collaborators: Uppsala University; The Netherlands Cancer Institute
• Investigators: Principal Investigator: Marta Lomnytska, MD, PhD, Uppsala University, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2018
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 077/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No