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Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (OVHIPEC-2)

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ClinicalTrials.gov Identifier: NCT03772028
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 21, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date May 23, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)		 overall survival [ Time Frame: 1 year after last patient last visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • recurrence-free survival [ Time Frame: 1 year after last patient last visit ]
  • adverse events [ Time Frame: 30 days after end of treatment ]
    toxicity of extra treatment compared standaard treatment
  • cost evaluation [ Time Frame: 1 year after lplv ]
    cost evaluation based measured by quality adjusted life year
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Official Title  ICMJE Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
Brief Summary stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
Detailed Description The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized controlled, open-label, multicenter phase III trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: cisplatin
HIPEC with cisplatin after cytoreductive surgery
Study Arms  ICMJE
  • No Intervention: conventional surgery
    Primary cytoreductive surgery without HIPEC
  • Experimental: HIPEC
    Primary cytoreductive surgery with HIPEC with cisplatin
    Intervention: Drug: cisplatin
Publications * Koole S, van Stein R, Sikorska K, Barton D, Perrin L, Brennan D, Zivanovic O, Mosgaard BJ, Fagotti A, Colombo PE, Sonke G, Driel WJV; OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group. Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial. Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)		 538
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2025
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • candidate for primary CRS
  • histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Exclusion Criteria:

  • history of previous malignancies within 5 years prior to inclusion
  • FIGO stage IV disease
  • complete primary cytoreduction is impossible
  • prior treatment for the current malignancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: ovarian cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Willemien van Driel, MD, PhD 0205129111 w.v.driel@nki.nl
Contact: Simone Koole 0205129111 s.koole@nki.nl
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772028
Other Study ID Numbers  ICMJE M17OVH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Netherlands Cancer Institute
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP