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

NCT ID: NCT03448354

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-26
• Study Completion Date: 2022-07-01

Brief Summary

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.

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NAC-IDS-HIPEC

Under the clinicians' decision, HIPEC procedures will be performed at the time of IDS.

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: PROCEDURE

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.

NAC-IDS

Under the clinicians' decision, HIPEC procedures will not be performed at the time of IDS.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Suk-Joon Chang

Director, Division of Gynecologic Oncology; Professor, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suk-Joon Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University

Locations

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jung-Yun Lee, MD, PhD

Role: CONTACT

yodrum682@gmail.com

+82-02-2228-2237

Facility Contacts

Suk-Joon Chang, MD, PhD

Role: primary

drchang@ajou.ac.kr

+82-31-219-5251

Other Identifiers

AJIRB-MED-OBS-17-324

Identifier Type: -

Identifier Source: org_study_id