Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

Ovarian Cancer Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03717610
• Other study ID #: 077/2018
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Uppsala University Hospital
• Contact: Marta Lomnytska, MD, PhD
• Phone: 018-611 00 00
• Email: marta.lomnytska[@]akademiska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer Recurrent
• Ovarian Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Sweden	Uppsala University Hopsital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University Hospital	The Netherlands Cancer Institute, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related toxicities	Registration of the effects according to NCI CTCAEv4.0 guidelines.	3 months after surgery
Secondary	Assessment of quality of life	EORTC C30 quality of life questionnaire	before surgery, and 4 weeks, 3 months and 6 months after surgery
Secondary	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
Secondary	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
Secondary	Morbidity	Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale	30 days after surgery
Secondary	Mortality	Number of participants with lethal outcome	90 days after surgery