Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
NCT ID: NCT05406674
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2022-06-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Patients in Arm B are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cisplatin- based HIPEC with a dosage of 40 mg/L perfusate.
TREATMENT
NONE
Study Groups
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Arm A
Patients in Arm A are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cispaltin-based HIPEC with a dosage of 100 mg/m2
Cisplatin 100 mg/m2
Cisplatin 100 mg/m2 milligram(s)/square meter
Arm B
Patients in Arm B are treated with interval cytoreductive surgery (with no more than 1 cm residual disease) and cisplatin- based HIPEC with a dosage of 40 mg/L perfusate.
Cisplatin 40 mg/l
Cisplatin 40 mg/I milligram(s)/litre
Interventions
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Cisplatin 100 mg/m2
Cisplatin 100 mg/m2 milligram(s)/square meter
Cisplatin 40 mg/l
Cisplatin 40 mg/I milligram(s)/litre
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. age ≥ 18 years
3. patients eligible for interval cytoreductive surgery
1. histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer
2. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8
3. neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel
4. following 2 cycles of chemotherapy no progression should occur
4. treated with optimal or complete interval cytoreductive surgery
5. fit for major surgery, WHO performance status 0-2
6. adequate bone marrow function (hemoglobin level \>5.5 mmol/L; leukocytes \>3 x 109/L; platelets \>100 x 109 /L)
7. adequate hepatic function (ALT, AST and bilirubin \<2.5 times upper limit of normal)
8. adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)
9. able to understand the patient information
Exclusion Criteria
2. opting for fertility-sparing surgery
18 Years
FEMALE
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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W. van Driel, MD PhD
Role: PRINCIPAL_INVESTIGATOR
NKI-AvL
Locations
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Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, , Netherlands
UMCU
Utrecht, , Netherlands
Countries
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Other Identifiers
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N21CCI
Identifier Type: -
Identifier Source: org_study_id
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