Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

NCT03717610 | Unknown

• 1 other identifier: 077/2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Treatment-related toxicities

  Registration of the effects according to NCI CTCAEv4.0 guidelines.

  3 months after surgery

Secondary Outcomes (5)

• Assessment of quality of life

  before surgery, and 4 weeks, 3 months and 6 months after surgery

• Assessment of quality of life in relation to ovarian cancer

  before surgery, and 4 weeks, 3 months and 6 months after surgery

• Assessment of quality of Life in relation to eventually performed intestinal surgery

  before surgery, and 4 weeks, 3 months and 6 months after surgery

• Morbidity

  30 days after surgery

• Mortality

  90 days after surgery

Study Arms (1)

Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min

EXPERIMENTAL

Procedure: radical surgery with HIPEC

Interventions

radical surgery with HIPEC PROCEDURE

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).

Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Uppsala University: collaborator
• The Netherlands Cancer Institute: collaborator

Study Sites (1)

Uppsala University Hopsital

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Marta Lomnytska, MD, PhD

  Uppsala University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Lomnytska, MD, PhD

CONTACT

018-611 00 00; marta.lomnytska@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 24, 2018
• Study Start: October 4, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)