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- Conditions
- Epithelial Ovarian Cancer stage IIIMedDRA version: 20.0Level: LLTClassification code 10006888Term: Ca ovarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033163Term: Ovarian epithelial cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003346-17-IT
- Lead Sponsor
- THE NETHERLANDS CANCER INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 538
Eligible patients must meet all of the following criteria:
1. signed and written informed consent
2. age =18
3. histological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer, treated with primary complete cytoreduction, or primary cytoreduction with no more than 2.5 mm residual disease
a. in case of extra-abdominal enlarged lymph nodes, representative cytology/histology or FDG-PET scan must be negative;
b. resectable, local bowel involvement or umbilical lesions are allowed;
c. in case no histological proof is available before surgery, patients can be randomized during surgery based on histological proof on intraoperative frozen
section material
4. fit for major surgery, WHO performance status 0-2
5. adequate bone marrow function (hemoglobin level >5.5 mmol/L; neutrophils >1.5 x 109/L; platelets >100 x 109 /L)
6. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)
a. in case of Gilbert’s disease: unconjugated bilirubin <5 times upper limit of normal
7. adequate renal function (creatinine clearance using Cockcroft –Gault formula = 60 ml/min2)
8. baseline health-outcome questionnaire should be completed before randomization
9. able to understand the patient information and questionnaires.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. history of previous malignancy treated with chemotherapy
2. history of previous malignancy within five years prior to inclusion, with the exception of carcinoma in situ of the cervix, radically excised basal cell or squamous cell cancer of the skin or synchronal endometrial carcinoma FIGO IA G1/2
3. if complete primary cytoreduction is not feasible, for the following reasons:
a. diffuse deep infiltration of the root of small bowel mesentery, or;
b. diffuse carcinomatosis of the small bowel that requires resection that leads to short bowel syndrome (remaining bowel <1.5 meter), or;
c. diffuse involvement/deep infiltration of stomach/duodenum, or;
d. diffuse involvement/deep infiltration of head or middle part of pancreas, or;
e. involvement of truncus coeliacus , hepatic arteries or left gastric artery, or;
f. non-resectable enlarged (larger than 10 mm short axis) lymph nodes
4. in case of a known psychiatric disorder, substance abuse disorder, or high suspicion of a mental disorder that could interfere with cooperation or compliance with the requirements of the trial
5. when opting for fertility sparing surgery, or when breastfeeding
6. in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2 antibodies)
7. in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative])
8. patients who received prior treatment for the current malignancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: - To compare recurrence-free survival between both treatment arms.<br>- To compare time to first subsequent anticancer treatment after first recurrent disease (TFST).;Primary end point(s): The primary endpoint is overall survival, defined as the time from randomization to the date of death from any cause.;Timepoint(s) of evaluation of this end point: NA;Main Objective: The primary objective of this study is to compare overall survival between treatment with primary cytoreductive surgery and HIPEC (intervention), and treatment with primary cytoreductive surgery without HIPEC (standard), in patients with FIGO stage III ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Recurrence-free survival, defined as the time between the date of randomization and the first date of documented disease progression or recurrence, as determined by the GCIG criteria in combination with clinical and/or radiological assessments, or death due to any cause, whichever occurs first.; The time to first subsequent anticancer treatment after first recurrent disease (TFST); The toxicity and morbidity, which will be reported until 30 days after the end of chemotherapy, using the Common Toxicity Criteria for Adverse Events (CTCAE 5.0) for all events, and using the Clavien-Dindo method for surgery-related events.;Timepoint(s) of evaluation of this end point: NA; NA; NA