Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03448354|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Procedure: HIPEC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|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)|
|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|
Under the clinicians' decision, HIPEC procedures will be performed at the time of IDS.
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.
- Progression free survival [ Time Frame: up to 5 years ]From the study enrollment to the disease progression
- Response rate [ Time Frame: up to 1 years ]rate of patients with partial or complete response (RECIST criteria version 1.1 ) after primary treatment
- Overall survival [ Time Frame: up to 5 years ]From study enrollment to the patients death
- Adverse drug reaction [ Time Frame: up to 1 years ]Incidence of grade 3 or 4 drug adverse reaction (NCI CTCAE version 4.03)
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
|Contact: Jung-Yun Lee, MD, PhDemail@example.com|
|Korea, Republic of|
|Ajou University Hospital||Recruiting|
|Suwon, Gyeonggi, Korea, Republic of, 16499|
|Contact: Suk-Joon Chang, MD, PhD +82-31-219-5251 firstname.lastname@example.org|
|Principal Investigator:||Suk-Joon Chang, MD, PhD||Ajou University|