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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448354
• Other study ID #: AJIRB-MED-OBS-17-324
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2019
• Source: Ajou University School of Medicine
• Contact: Jung-Yun Lee, MD, PhD
• Phone: +82-02-2228-2237
• Email: yodrum682[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	From the study enrollment to the disease progression	up to 5 years
Secondary	Response rate	rate of patients with partial or complete response (RECIST criteria version 1.1 ) after primary treatment	up to 1 years
Secondary	Overall survival	From study enrollment to the patients death	up to 5 years
Secondary	Adverse drug reaction	Incidence of grade 3 or 4 drug adverse reaction (NCI CTCAE version 4.03)	up to 1 years