Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT03717610
• Recruitment Status: Recruiting
• First Posted: October 24, 2018
• Last Update Posted: October 8, 2021
• Sponsor: Uppsala University Hospital
• Collaborators: Uppsala University; The Netherlands Cancer Institute
• Information provided by (Responsible Party): Marta Lomnytska, Uppsala University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer Recurrent	Procedure: radical surgery with HIPEC	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: October 4, 2018
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Treatment-related toxicities [ Time Frame: 3 months after surgery ]
   Registration of the effects according to NCI CTCAEv4.0 guidelines.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Contacts

Contact: Marta Lomnytska, MD, PhD; 018-611 00 00 ext +46; marta.lomnytska@akademiska.se

Locations

Sweden

Uppsala University Hopsital; Recruiting

Uppsala, Sweden, 75185

Contact: Marta Lomnytska, PhD 018-611 00 00 ext +46 marta.lomnytska@akademiska.se

Contact: Ilvars Silins, PhD 018-611 00 00 ext +46 ilvars.silins@akademiska.se

Sub-Investigator: Wilhelm Graf, Professor

Sponsors and Collaborators

Uppsala University Hospital

Uppsala University

The Netherlands Cancer Institute

Investigators

• Principal Investigator: Marta Lomnytska, MD, PhD; Uppsala University, Sweden

More Information

• Responsible Party: Marta Lomnytska, Principal Investigator, Uppsala University Hospital
• ClinicalTrials.gov Identifier: NCT03717610
• Other Study ID Numbers: 077/2018
• First Posted: October 24, 2018
• Last Update Posted: October 8, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type