Ovarian Cancer
Conditions
Keywords
ovarian cancer, HIPEC, OVHIPEC, primary debulking
Brief summary
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
Detailed 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.
Interventions
DRUGcisplatin
HIPEC with cisplatin after cytoreductive surgery
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled, open-label, multicenter phase III trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 1 year after last patient last visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence-free survival | 1 year after last patient last visit | — |
| adverse events | 30 days after end of treatment | toxicity of extra treatment compared standaard treatment |
| cost evaluation | 1 year after lplv | cost evaluation based measured by quality adjusted life year |
Countries
Denmark, France, Ireland, Italy, Netherlands, Sweden, United States
Outcome results
None listed