Phase III Randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy: OVHIPEC-2
- Conditions
- 10038594ovarian cancer
- Registration Number
- NL-OMON55839
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
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, iatrogenic abdominal wall
metastases 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, hepatic function and renal function
6. baseline health-outcome questionnaire should be completed before
randomization
7. able to understand the patient information and questionnaires.
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, 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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is overall survival, defined as the time from<br /><br>randomization to the date of death from any cause. For subjects that are alive,<br /><br>their survival time will be censored at the date of last contact (*last known<br /><br>alive date*). Overall survival will be censored for subjects at the date of<br /><br>randomization if they were randomized but had no follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In addition, we will also investigate whether HIPEC influences disease-free<br /><br>survival, the time until the next treatment after the first recurrence, the<br /><br>side effects and quality of life. We will also investigate whether the<br /><br>treatment is cost effective. We will also do additional biomarker research of<br /><br>mutations in the tissue and blood.</p><br>