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

NCT03448354 | Unknown

• 1 other identifier: AJIRB-MED-OBS-17-324
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

HIPEC; Interval debulking surgery

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From the study enrollment to the disease progression

  up to 5 years

Secondary Outcomes (3)

• Response rate

  up to 1 years

• Overall survival

  up to 5 years

• Adverse drug reaction

  up to 1 years

Study Arms (2)

NAC-IDS-HIPEC

EXPERIMENTAL

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

Procedure: HIPEC

NAC-IDS

NO INTERVENTION

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

Interventions

HIPEC 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-HIPEC

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients histologically diagnosed with EOC (epithelial ovarian cancer), fallopian tubal cancer or primary peritoneal cancer.
• patients treated with neoadjuvant chemotherapy (NAC) followed by interval debulking surgery due to expected suboptimal residual disease at the time of primary surgery.
• patients who had diagnostic laparoscopy before NAC and confirmed with tumor burden, Fagotti score ≥8.
• ECOG performance status (0\~2)
• 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
• Live expenctancy \> 6 month
• Age \> 19 years old

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Suk-Joon Chang, MD, PhD

  Ajou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Yun Lee, MD, PhD

CONTACT

+82-02-2228-2237; yodrum682@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Gynecologic Oncology; Professor, Department of Obstetrics and Gynecology

Model Details: Comparative effectiveness of HIPEC following interval debulking surgery in patients with advanced-stage ovarian cancer undergoing neoadjuvant chemotherapy: Multicenter, prospective, cohort study

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: October 26, 2017
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

KR (1)