CisCon: Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer

• Sponsor: The Netherlands Cancer Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05406674
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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. Worldwide, two established strategies exist for dosing of HIPEC protocols, which follow either a body surface area (BSA)-based or a concentration-based approach. Since both strategies result in different exposure to intra-peritoneal chemotherapy, we aim to compare the pharmacokinetics and safety of both strategies.

Condition or Disease	Intervention/Treatment	Phase
FIGO Stage III Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Carcinoma	Drug: Cisplatin 100 mg/m2; Drug: Cisplatin 40 mg/l	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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. 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.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. 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Cisplatin 100 mg/m2; Cisplatin 100 mg/m2 milligram(s)/square meter; Other Names: LO1XA NDC 16729-288 SUB07483MIG PL 20075/0123
Experimental: 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.	Drug: Cisplatin 40 mg/l; Cisplatin 40 mg/I milligram(s)/litre; Other Names: LO1XA NDC 16729-288 SUB07483MIG PL 20075/0123

Outcome Measures

Primary Outcome Measures

1. Intratumoral platinum (Pt) concentration at the end of perfusion after 90 minutes (in ng/mg wet tissue) [End of perfusion after 90 minutes]

Secondary Outcome Measures

1. Toxicity evaluation (CTCAE 5.0) [The occurrence of adverse events will be monitored until 6 weeks after surgery]

   Grade 3-5 will be reported

2. Platinum (Pt) concentration in normal tissue (in ng/mg wet tissue) [End of perfusion]

3. Platinum (Pt) concentration in tumor tissue after 30 minutes and 60 minutes of perfusion (in ng/mg wet tissue) [After 30 minutes and 60 minutes of perfusion]

4. Concentration versus time curve and area-under-the-curve (AUC) of intra-peritoneal Platinum (Pt) during perfusion [During perfusion]

5. Maximum Concentration (Cmax) Platinum (Pt) in perfusate during perfusion [During perfusion]

6. Time to Maximum Concentration (Tmax) Platinum (Pt) in perfusate during perfusion [During perfusion]

7. Terminal elimination half-life (t1/2) Platinum (Pt) in perfusate during perfusion [During perfusion]

8. Clearance from perfusate at the end of perfusion [End of perfusion]

9. Overall Survival (OS) [Will be evaluated after 3 and 5 years after the last patient last visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. signed and written informed consent

2. age ≥ 18 years

3. patients eligible for interval cytoreductive surgery

4. histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer

5. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8

6. neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel

7. following 2 cycles of chemotherapy no progression should occur

8. treated with optimal or complete interval cytoreductive surgery

9. fit for major surgery, WHO performance status 0-2

10. adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)

11. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)

12. 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)

13. able to understand the patient information

Exclusion Criteria:

1. history of previous malignancy treated with chemotherapy

2. opting for fertility-sparing surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antoni van Leeuwenhoek (NKI-AVL)	Amsterdam		Netherlands	1066 CX

Sponsors and Collaborators

• The Netherlands Cancer Institute

Investigators

• Principal Investigator: W. van Driel, MD PhD, NKI-AvL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Netherlands Cancer Institute
• ClinicalTrials.gov Identifier: NCT05406674
• Other Study ID Numbers: N21CCI
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Cisplatin

Study Results

No Results Posted as of Jun 6, 2022