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Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy: OVHIPEC-2
EU CTIS ID: 2023-509049-11-00
What this study is testing
The primary objective of this study is to evaluate the effect of HIPEC on overall survival when added to primary cytoreductive surgery in patients with FIGO stage III ovarian cancer who are eligible for primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- signed and written informed consent
- age ≥18
- 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 suspicious 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
- fit for major surgery, WHO performance status 0-2
- adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)
- 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
You likely can't join if
- history of previous malignancy treated with chemotherapy
- 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
- 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
- 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
- when opting for fertility sparing surgery, or when breastfeeding
- in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2 antibodies)
See the full eligibility criteria
- signed and written informed consent
- age ≥18
- 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 suspicious 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
- fit for major surgery, WHO performance status 0-2
- adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)
- 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
- adequate renal function (creatinine clearance ≥ 60 ml/min or ml/min/1,73 m2 using either MDRD, Cockcroft-Gault formula, or CKD-EPI)
- baseline health-outcome questionnaire should be completed before randomization
- able to understand the patient information and questionnaires.
- history of previous malignancy treated with chemotherapy
- 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
- 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
- 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
- when opting for fertility sparing surgery, or when breastfeeding
- in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2 antibodies)
- in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative])
- patients who received prior treatment for the current malignancy
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- India
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; India; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.