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New treatment option for Ovarian Cancer
Official title Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
ClinicalTrials.gov ID: NCT04282356
What this study is testing
What is Intraperitoneal chemotherapy during surgery?
Intraperitoneal chemotherapy during surgery is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as Intraperitoneal chemotherapy after surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Patients aged 18 to 75 years,
- Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive...
- Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability,
- Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion (measured on a thoracic CT scanner, the largest thickness of which...
- Complete interval cytoreduction surgery,
You likely can't join if
- Performance Index (WHO) ≥ 2,
- Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm),
- Renal impairment (clearance \<70 ml / min) according to the MDRD method,
- General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments...
- Hepatic insufficiency (bilirubin \> 1.5 x normal, ASAT \& ALAT \> 3 x upper limit of normal),
- Serious life-threatening co-existing condition at stake,
See the full eligibility criteria
- Patients aged 18 to 75 years,
- Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer,
- Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability,
- Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is less than 3 cm),
- Complete interval cytoreduction surgery,
- Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination,
- The delay between the last course of NAT and the surgery must be between 4 and 8 weeks,
- Hematologic function, hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 109 / L, platelets ≥ 100 x 109 / L,
- Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN,
- Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method,
- Informed consent signed before any specific procedure under consideration,
- Patients affiliated to the French social security scheme or equivalent.
- Performance Index (WHO) ≥ 2,
- Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm),
- Renal impairment (clearance \<70 ml / min) according to the MDRD method,
- General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components),
- Hepatic insufficiency (bilirubin \> 1.5 x normal, ASAT \& ALAT \> 3 x upper limit of normal),
- Serious life-threatening co-existing condition at stake,
- Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC,
- Patient who has already been treated with chemo-hyperthermia for ovarian cancer,
- History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial,
- Any severe untreated infectious disease,
- Peripheral sensory neuropathy ≥ grade 2 at the inclusion time,
- Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons,
- Pregnant and / or nursing women,
- people under tutelage, curatorship or safeguard of justice.
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. 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 ClinicalTrials.gov; the study team decides eligibility.