This study has been transitioned to CTIS with ID 2024-514711-99-00 check the CTIS register for the current data. To evaluate BSA-based versus concentration-based OVHIPEC with cisplatin in patients with advanced-stage ovarian cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is platinum concentration in the tumor nodule at the end of
the HIPEC procedure.
Secondary outcome
Secondary endpoints are pharmacokinetic parameters (AUCip, Cmax, Tmax, t1/2 in
perfusate, clearance from abdominal cavity), platinum concentration in normal
tissue, platinum concentration in tumor tissue after 30 min and 60 min of
perfusion, and post-operative complications (CTCAE 5.0), Recurrence-free
survival (RFS) and Overall survival (OS)
Background summary
Cytoreductive surgery (CRS) with the addition of hyperthermic intraperitoneal
chemotherapy (HIPEC) is used in current clinical practice in selected patients
with advanced ovarian cancer. Clinical evidence for the benefit of HIPEC in
ovarian cancer comes from the pivotal phase 3 OVHIPEC trial [1]. Worldwide, two
established strategies exist for dosing of HIPEC protocols, which follow either
a body surface area (BSA)-based or a concentration-based approach [1-4]. Since
both strategies result in different exposure to intra-peritoneal chemotherapy,
we aim to compare the pharmacokinetics and safety of both strategies.
Study objective
This study has been transitioned to CTIS with ID 2024-514711-99-00 check the CTIS register for the current data.
To evaluate BSA-based versus concentration-based OVHIPEC with cisplatin in
patients with advanced-stage ovarian cancer.
Study design
Single-center phase II randomized study
Intervention
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, with a maximum dose of 220 mg
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.
Study burden and risks
Previous studies have shown that both dosing regimens are safe. We do not
expect to observe a significant difference in adverse events. Peritoneal
biopsies for research during and at the end of the HIPEC procedure do not lead
to additional risks after performing extensive cytoreductive surgery.
Participation does not require extra hospital visits or examinations and
regular follow-up will be in place for both arms.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
1. signed and written informed consent
2. age >= 18 years
3. patients eligible for interval cytoreductive surgery with OVHIPEC
a. histological proven FIGO stage III primary high grade serous ovarian,
fallopian tube, or extra-ovarian cancer
b. when only cytology is performed to confirm the diagnosis ovarian carcinoma,
immunohistochemistry including keratin 7, keratin 20, p53, PAX8 should be
considered (at the discretion of the pathologist)
c. neo-adjuvant chemotherapy consists of (at least) 3 courses of
carboplatin/paclitaxel
d. following 2 cycles of chemotherapy no progression should occur
e. resectable, local bowel involvement, iatrogenic abdominal wall metastases or
umbilical lesions (which is stage IV) are allowed;
4. peritoneal disease present at the start of cytoreductive surgery
5. treated with optimal or complete interval cytoreductive surgery
6. fit for major surgery, WHO performance status 0-2
7. adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x
109/L; platelets >100 x 109 /L)
8. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of
normal)
9. 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)
10. able to understand the patient information
Exclusion criteria
1. history of previous malignancy treated with chemotherapy
2. opting for fertility-sparing surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514711-99-00 |
| EudraCT | EUCTR2021-006809-29-NL |
| ClinicalTrials.gov | NCT05406674 |
| CCMO | NL80234.031.22 |