Actively Recruiting
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12
55
Participants Needed
1
Research Sites
532 weeks
Total Duration
On this page
Sponsors
I
Institut du Cancer de Montpellier - Val d'Aurelle
Lead Sponsor
D
Direction Générale de l'Offre de Soins
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clinicians postulate that it may be interesting to combine the two IntraPeritoneal (IP) treatments associated with a significant improvement of OC overall survival i.e. cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC) as an " intensive peritoneal " regimen in the initial management of stages III-IVA ovarian cancers. Performing a postoperative IPC may allow completing and extending the duration of the effect of HIPEC in decreasing the risk of peritoneal recurrence. HIPEC may also allow administering an early IP treatment on the residual microscopic disease during initial or interval surgery with an optimal access to the intraperitoneal cavity. Postoperative IPC will extend the HIPEC effect on unsterilized peritoneal microscopic residues with the aim of decreasing the risk of local recurrence. Performing HIPEC before IPC could allow limiting the number of postoperative IP courses needed. Nevertheless, this association questions its feasibility and tolerance, which should both be assessed in a phase II trial. Clinicians propose to conduct this feasibility study combining for the first time HIPEC with IPC as first-line treatment of ovarian cancer with peritoneal carcinomatosis to perform a peritoneal intensification.
CONDITIONS
Official Title
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Histologically confirmed high-grade serous ovarian, tubal, or primary peritoneal cancer
- Initial laparoscopy confirming histology, disease extent by PCI score, and non-resectability
- Stage III B-C or stage IVA with minimal/moderate pleural effusion (less than 3 cm thickness)
- Complete interval cytoreductive surgery
- Planned 3 to 4 courses of neoadjuvant chemotherapy with carboplatin and paclitaxel
- Interval between last chemotherapy and surgery between 4 and 8 weeks
- Hematologic function with hemoglobin ≥10 g/dl, neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L
- Total bilirubin ≤1.5 times normal, ALT and AST ≤3 times upper limit of normal
- No renal insufficiency (creatinine clearance ≥70 ml/min by MDRD method)
- Signed informed consent
- Affiliated with French social security or equivalent
You will not qualify if you...
- Performance status (WHO) ≥2
- Stage IV B or stage IV A with significant pleural effusion (greater than 3 cm thickness)
- Renal impairment (creatinine clearance <70 ml/min by MDRD method)
- Contraindication or allergy to tumor reduction surgery or HIPEC components
- Hepatic insufficiency (bilirubin >1.5 times normal, AST or ALT >3 times upper limit)
- Serious life-threatening co-existing conditions
- Cardio-respiratory conditions requiring hyperhydration for HIPEC
- Previous chemo-hyperthermia treatment for ovarian cancer
- History of cancer except basal cell carcinoma of skin or cervical carcinoma in situ within past 5 years
- Severe untreated infections
- Peripheral sensory neuropathy grade 2 or higher at inclusion
- Inability to attend regular follow-up for psychological, social, family, or geographic reasons
- Pregnant or nursing women
- Individuals under legal guardianship or protection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
Research Team
A
Aurore MOUSSION
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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