Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer

Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer Undergoing Neoadjuvant Chemotherapy: Multicenter, Prospective, Cohort Study

Ovarian cancer is a lethal malignancy and reported as a fifth leading cause of death in all age in the developed country. Most of the ovarian cancer patients are diagnosed at advanced stages due to an inadequate screening tool and a lack of clinical symptoms. Optimal cytoreductive surgery with no gross residual disease followed platinum-based adjuvant chemotherapy has been the most effective therapeutic strategy in the treatment of advanced ovarian cancer. However, the optimal surgical procedure is not always possible, especially in patients with extensive disease or women with poor performance status. Neoadjuvant chemotherapy(NAC) followed interval debulking surgery (IDS) is an alternative therapeutic option for these patients. There is growing interest in the use of HIPEC (hyperthermic intraperitoneal chemotherapy) for ovarian cancer, and early data on HIPEC as a component of front-line therapy of advanced ovarian cancer are encouraging. However, intraperitoneal chemotherapy is not actively used in the treatment of ovarian cancer due to the catheter-related complications or inconvenience. The aim of this study is to evaluate the effectiveness and safety of HIPEC after interval debulking surgery in advanced ovarian cancer patients.

Study Overview

• Status: Unknown
• Conditions: Ovarian Cancer
• Intervention / Treatment: Procedure: HIPEC

Detailed Description

GOG 172 trial showed a dramatic improvement of overall survival in patients with stage III disease treated with intraperitoneal cisplatin and paclitaxel compared with those with intravenous administration. Currently, prospective cohort study showed a survival benefit of intraperitoneal chemotherapy compared with intravenous chemotherapy. Despite this improvement, intraperitoneal chemotherapy is not widely used as standard therapy owing to the high rate of adverse effects and inconvenience of administering therapy intraperitoneally. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a multi-modal approach with combined intraperitoneal chemotherapy and hyperthermia. It maintains the theoretical benefit of intraperitoneal chemotherapy and reduces most of the adverse events from catheter-related problems with delivery of the chemotherapeutic agent at the end of surgery. In addition, hyperthermia increases the penetration of chemotherapy at the peritoneal surface and chemo-sensitivity. In this trial, we aim to evaluate the efficacy and safety of HIPEC procedures performed after interval debulking surgery in patients with advanced ovarian cancer.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Yun Lee, MD, PhD; Phone Number: +82-02-2228-2237; Email: yodrum682@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Suwon, Gyeonggi, Korea, Republic of, 16499
      • Recruiting
      • Ajou University Hospital
      • Contact: Suk-Joon Chang, MD, PhD; Phone Number: +82-31-219-5251; Email: drchang@ajou.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. patients histologically diagnosed with EOC (epithelial ovarian cancer), fallopian tubal cancer or primary peritoneal cancer.
2. patients treated with neoadjuvant chemotherapy (NAC) followed by interval debulking surgery due to expected suboptimal residual disease at the time of primary surgery.
3. patients who had diagnostic laparoscopy before NAC and confirmed with tumor burden, Fagotti score ≥8.
4. ECOG performance status (0~2)
5. lab findings Bone marrow function : ANC>1,500/mm3, Platelet >100,000/mm3, Hemoglobin>10.0g/dl Kidney function : creatinine<1.25xUNL Liver function: AST, ALT< x1.5UNL, bilirubin<1.5mg/dl
6. Live expenctancy > 6 month
7. Age > 19 years old

Exclusion Criteria:

1. Patients with treated with primary debulking surgery
2. Patients with double primary cancer ( exception: patients with early breast cancer or endometrial cancer that will not affect the clinical course of ovarian cancer)
3. Patients with pregnant or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NAC-IDS-HIPEC; Under the clinicians' decision, HIPEC procedures will be performed at the time of IDS.	Procedure: HIPEC; HIPEC(paclitaxel 175mg/m2, 90min; open or closed technique) after IDS . IDS is recommended within 4 weeks after the 3rd NAC cycle. HIPEC procedure is allowed only in case of residual disease less than 5mm.
NO_INTERVENTION: NAC-IDS; Under the clinicians' decision, HIPEC procedures will not be performed at the time of IDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	From the study enrollment to the disease progression	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	rate of patients with partial or complete response (RECIST criteria version 1.1 ) after primary treatment	up to 1 years
Overall survival	From study enrollment to the patients death	up to 5 years
Adverse drug reaction	Incidence of grade 3 or 4 drug adverse reaction (NCI CTCAE version 4.03)	up to 1 years

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Suk-Joon Chang, MD, PhD, Ajou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2017
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: HIPEC; Interval debulking surgery
• 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: AJIRB-MED-OBS-17-324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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