Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (OVHIPEC-2)
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| ClinicalTrials.gov Identifier: NCT03772028 |
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Recruitment Status :
Recruiting
First Posted : December 11, 2018
Last Update Posted : October 18, 2022
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Sponsor:
The Netherlands Cancer Institute
Information provided by (Responsible Party):
The Netherlands Cancer Institute
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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 |
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 |
| Actual Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | April 1, 2025 |
| Estimated Study Completion Date : | April 1, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
Drug Information available for:
Cisplatin
| Arm | Intervention/treatment |
|---|---|
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No Intervention: conventional surgery
Primary cytoreductive surgery without HIPEC
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Experimental: HIPEC
Primary cytoreductive surgery with HIPEC with cisplatin
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Drug: cisplatin
HIPEC with cisplatin after cytoreductive surgery |
Primary Outcome Measures :
- overall survival [ Time Frame: 1 year after last patient last visit ]
Secondary Outcome Measures :
- 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
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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 | 031 20 512 7918 | OVHIPEC@nki.nl | |
| Contact: Lot Aronson | 031 20 512 7918 | OVHIPEC@nki.nl |
Locations
Show 21 study locations
Sponsors and Collaborators
The Netherlands Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Netherlands Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT03772028 |
| Other Study ID Numbers: |
M17OVH ENGOT-ov52/DGOG/OVHIPEC-2 ( Other Identifier: European Network of Gynaecological Oncological trials Groups ) |
| First Posted: | December 11, 2018 Key Record Dates |
| Last Update Posted: | October 18, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by The Netherlands Cancer Institute:
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ovarian cancer HIPEC OVHIPEC primary debulking |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Cisplatin Antineoplastic Agents |