Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (OVHIPEC-2)

Netherlands Cancer Institute (NKI)

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03772028

M17OVH

ENGOT-ov52/DGOG/OVHIPEC-2 (Other Identifier)

Details and patient eligibility

About

stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

Full description

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.

Enrollment: 538 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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538 participants in 2 patient groups

conventional surgery

No Intervention group

Description:

Primary cytoreductive surgery without HIPEC

HIPEC

Experimental group

Description:

Primary cytoreductive surgery with HIPEC with cisplatin

Treatment:

Drug: cisplatin