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

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

Brief Summary:
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: cisplatin Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled, open-label, multicenter phase III trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2025


Arm Intervention/treatment
No Intervention: conventional surgery
Primary cytoreductive surgery without HIPEC
Experimental: HIVEC
Primary cytoreductive surgery with HIPEC with cisplatin
Drug: cisplatin
HIVEC with cisplatin after cytoreductive surgery




Primary Outcome Measures :
  1. overall survival [ Time Frame: 1 year after last patient last visit ]

Secondary Outcome Measures :
  1. recurrence-free survival [ Time Frame: 1 year after last patient last visit ]
  2. adverse events [ Time Frame: 30 days after end of treatment ]
    toxicity of extra treatment compared standaard treatment

  3. cost evaluation [ Time Frame: 1 year after lplv ]
    cost evaluation based measured by quality adjusted life year



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   ovarian cancer
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03772028


Contacts
Contact: Willemien van Driel, MD, PhD 0205129111 w.v.driel@nki.nl
Contact: Simone Koole 0205129111 s.koole@nki.nl

Sponsors and Collaborators
The Netherlands Cancer Institute

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03772028     History of Changes
Other Study ID Numbers: M17OVH
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Fever
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Body Temperature Changes
Signs and Symptoms
Cisplatin
Antineoplastic Agents