A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patients

Phase III Randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy: OVHIPEC-2 - OVHIPEC2

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003346-17-NL

Enrollment

530

Registered

2019-04-18

Start date

2019-04-18

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stage III epithelial ovarian cancer

Interventions

Trade Name: Cisplatin Product Name: cisplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 15663-27-1 Concentration unit: mg/m2 milligram(s)/sq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - signed and written informed consent - age =18 - candidate for primary CRS, in whom a complete cytoreduction, or cytoreducion with no more than 2.5 mm residual disease is considered feasible - histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer - fit for major surgery, ASA 1 or ASA 2 - WHO performance status 0 t/m2 - adequate bone marrow, hepatic and renal function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. history of previous malignancies within 5 years prior to inclusion 2. FIGO stage IV disease 3. if complete primary cytoreduction is impossible 4. patients who received prior treatment for the current malignancy

Design outcomes

Primary

Measure	Time frame
Main Objective: to determine the beneficial effect of primary cytoreductive surgery (CRS) in combination with HIPEC (treatment arm) compared to primary CRS without HIPEC (standard arm), in patients with FIGO stage III ovarian cancer, who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm;Secondary Objective: -To show the addition of HIPEC improves recurrence-free survival -To evaluate the toxicity and morbidity of both treatment arms -To evaluate the quality of life of the treatment arm compared to the standard arm -To assess genetic profiles predictive of tumor response in patients with stage III ovarian cancer undergoing primary CRS with or without HIPEC -To assess an economic- and cost evaluation of the procedure ;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: after 1 year of follow up	—

Measure

Time frame

Main Objective: to determine the beneficial effect of primary cytoreductive surgery (CRS) in combination with HIPEC (treatment arm) compared to primary CRS without HIPEC (standard arm), in patients with FIGO stage III ovarian cancer, who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm;Secondary Objective: -To show the addition of HIPEC improves recurrence-free survival -To evaluate the toxicity and morbidity of both treatment arms -To evaluate the quality of life of the treatment arm compared to the standard arm -To assess genetic profiles predictive of tumor response in patients with stage III ovarian cancer undergoing primary CRS with or without HIPEC -To assess an economic- and cost evaluation of the procedure ;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: after 1 year of follow up

—

Secondary

Measure	Time frame
Secondary end point(s): - Recurrence-free survival - The toxicity and morbidity of both treatment arms - The quality of life of both treatment arms - Economic- and cost evaluation of the procedure;Timepoint(s) of evaluation of this end point: RFS, QoL and cost effectiveness: after 6 years (after one year of follow up) safety: after 30 days after last treatment	—

Countries

Denmark, France, Italy, Netherlands, Sweden

Contacts

Public ContactSimone Koole

NKI-AVL

s.koole@nki.nl0031205129111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026