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Hyperthermic Intraperitoneal Chemotherapy in the treatment of Ovarian Cancer relapse
EU CTIS ID: 2024-517390-24-00
What this study is testing
To improve overall survival at 12 months for patients in arm with HIPEC compared with patients in arm without HIPEC.
- 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
- Patient age ≥ 18 years,
- Hematological functions : PNN > ou = 1.5x109/L, platelets > ou = 100x109/L,
- No contraindication to general anesthesia for heavy surgery
- Patient must be informed and the Informed Consent Form signed before any study-specific procedures start.
- Medical/Public Health insurance coverage
- Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
You likely can't join if
- Patient age <18 years,
- Non-epithelial ovarian tumor,
- Uncontrolled infection,
- Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
- Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
- Patient who has already been treated by HIPEC for ovarian cancer,
See the full eligibility criteria
- Patient age ≥ 18 years,
- Hematological functions : PNN > ou = 1.5x109/L, platelets > ou = 100x109/L,
- No contraindication to general anesthesia for heavy surgery
- Patient must be informed and the Informed Consent Form signed before any study-specific procedures start.
- Medical/Public Health insurance coverage
- Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
- Performance Status WHO < 2,
- Previous treatment for epithelial ovarian cancer, tubal peritoneal primitive
- Patient with intraperitoneal relapse (more than 6 months after the end of the initial treatment), resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
- Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)
- Complete cytoreductive surgery,
- Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 weeks
- No hepatic insufficiency (bilirubin ≤ 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT ≤ 3 ULN,
- No renal insufficiency (creatinine ≤ 1.5 ULN, creatinine clearance >60 ml/min) calculated with MDRD method,
- Patient age <18 years,
- Non-epithelial ovarian tumor,
- Uncontrolled infection,
- Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
- Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
- Patient who has already been treated by HIPEC for ovarian cancer,
- Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
- Pregnant or breastfeeding woman
- Patient who has already been enrolled in another clinical trial
- Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
- Known hypersensitivity to cisplatin,
- Metastasis,
- Use of anti-angiogenic treatment within 8 weeks before surgery
- Patient with other concomitant severe life threatening disease,
- More than 2 segmental resections concomitant to HIPEC is foreseen,
- Any progressive disease during the second-line chemotherapy (platine-based),
- Relapse occurring less than 6 months after the end of the initial treatment,
The study team makes the final eligibility decision.
Where it's taking place
- Canada
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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. 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.