Cancer of the ovary.
Stephen A Cannistra
https://pubmed.ncbi.nlm.nih.gov/15590954Actively Recruiting
Phase 2
Age: 18Years - 75Years
FEMALE
ID04282356
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer Combining Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Postoperative Intraperitoneal Chemotherapy (IPC)
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12
55
Participants Needed
1
Research Sites
208 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
This research investigates a new approach to treat advanced ovarian cancer, specifically stages III to IVA with peritoneal carcinomatosis. The study evaluates combining two intraperitoneal chemotherapy methods: cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC). This combination is proposed to extend and enhance the effects of treatment against microscopic cancer cells in the peritoneal cavity, aiming to reduce the risk of local recurrence after surgery. The trial is a phase II feasibility study assessing both the possibility and tolerance of this combined approach. Participants will undergo interval surgery including HIPEC with cisplatin administered during surgery, followed by postoperative IPC involving intravenous and intraperitoneal chemotherapy drugs (Paclitaxel and Carboplatin). At least three chemotherapy courses will be given, with up to six allowed depending on clinical strategy. The HIPEC is delivered as a 1.5-hour infusion with renal protection, and IPC courses are scheduled on specific days after surgery. If intraperitoneal administration is not possible, intravenous chemotherapy will be substituted. Patients will be closely monitored throughout the treatment period, which includes up to six months after surgery for chemotherapy completion and safety surveillance. Assessments include chemotherapy administration success, safety and toxicity of HIPEC and IPC, postoperative complications, and relapse-free survival tracked up to five years. The study involves initial laparoscopy for diagnosis and staging, regular safety evaluations, and follow-up visits to measure treatment outcomes and tolerability.
CONDITIONS
Brief Title
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
Who Can Participate
Age: 18Years - 75Years
FEMALE
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 and disease extent with non-resectable disease
- Stage III B-C or stage IVA with minimal or moderate pleural effusion less than 3 cm
- Complete interval cytoreductive surgery performed
- Planned 3 to 4 courses of neoadjuvant chemotherapy with Carboplatin-Paclitaxel
- Surgery performed 4 to 8 weeks after last chemotherapy course
- Adequate hematologic function: hemoglobin ≥10 g/dl, neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L
- Liver function within limits: bilirubin ≤1.5 times normal, ALT/AST ≤3 times upper normal limit
- No renal insufficiency with creatinine clearance ≥70 ml/min
- Signed informed consent
- Affiliated with French social security or equivalent
You will not qualify if you...
- WHO performance status 2 or higher
- Stage IV B or stage IVA with significant pleural effusion greater than 3 cm
- Renal impairment with creatinine clearance below 70 ml/min
- Contraindications to tumor reduction surgery or HIPEC, including allergic reactions
- Hepatic insufficiency with bilirubin >1.5 times normal or elevated liver enzymes
- Serious life-threatening coexisting conditions
- Cardio-respiratory conditions preventing required hydration for HIPEC
- Prior treatment with chemo-hyperthermia for ovarian cancer
- History of other cancers except certain skin or cervical cancers within 5 years
- Untreated severe infectious diseases
- Peripheral sensory neuropathy grade 2 or higher at inclusion
- Inability to comply with regular follow-up due to psychological, social, or geographic reasons
- Pregnant or nursing women
- Persons under legal guardianship or similar protections
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for exploratory laparoscopy with biopsies and disease evaluation
Surgery and Immediate Post-operative Care
Duration - 1 day (surgery) plus immediate recovery period
Participants undergo complete cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery to target microscopic disease.
1 surgical procedure with hospital stay for recovery
Treatment
Duration - At least 3 courses, up to 4-6 courses over approximately 6 months
After surgery, participants receive postoperative intraperitoneal chemotherapy (IPC) combined with intravenous chemotherapy consisting of multiple courses to extend the treatment effect and reduce recurrence risk.
Chemotherapy administered on Day 1 and Day 8 of each course, with multiple visits over 6 months
Surveillance
Duration - Up to 5 years after treatment completion
Participants are monitored for safety and treatment effects following completion of chemotherapy courses.
Periodic follow-up visits for safety and relapse-free survival monitoring
Trial Site Locations
Total: 1 location
1
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
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Research Team
A
Aurore MOUSSION
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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Published Research Related To This Trial
Aggressive surgical strategies in advanced ovarian cancer: a monocentric study of 203 stage IIIC and IV patients.
P-E Colombo, A Mourregot, M Fabbro...
https://pubmed.ncbi.nlm.nih.gov/18289825Intraperitoneal cisplatin and paclitaxel in ovarian cancer.
Deborah K Armstrong, Brian Bundy, Lari Wenzel...
https://pubmed.ncbi.nlm.nih.gov/16394300Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer.
Willemien J van Driel, Simone N Koole, Karolina Sikorska...
https://pubmed.ncbi.nlm.nih.gov/29342393