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

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ClinicalTrials.gov Identifier: NCT03448354
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Suk-Joon Chang, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: HIPEC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative effectiveness of HIPEC following interval debulking surgery in patients with advanced-stage ovarian cancer undergoing neoadjuvant chemotherapy: Multicenter, prospective, cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer Undergoing Neoadjuvant Chemotherapy: Multicenter, Prospective, Cohort Study
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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.



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 5 years ]
    From the study enrollment to the disease progression


Secondary Outcome Measures :
  1. Response rate [ Time Frame: up to 1 years ]
    rate of patients with partial or complete response (RECIST criteria version 1.1 ) after primary treatment

  2. Overall survival [ Time Frame: up to 5 years ]
    From study enrollment to the patients death

  3. Adverse drug reaction [ Time Frame: up to 1 years ]
    Incidence of grade 3 or 4 drug adverse reaction (NCI CTCAE version 4.03)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448354


Contacts
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Contact: Jung-Yun Lee, MD, PhD +82-02-2228-2237 yodrum682@gmail.com

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Gyeonggi, Korea, Republic of, 16499
Contact: Suk-Joon Chang, MD, PhD    +82-31-219-5251    drchang@ajou.ac.kr   
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Suk-Joon Chang, MD, PhD Ajou University

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Responsible Party: Suk-Joon Chang, Director, Division of Gynecologic Oncology; Professor, Department of Obstetrics and Gynecology, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03448354     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-17-324
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suk-Joon Chang, Ajou University School of Medicine:
HIPEC
Interval debulking surgery
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma