Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04282356
Eligibility Criteria:
Inclusion 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.
Exclusion Criteria:
* 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,
* Subjects under tutelage, curatorship or safeguard of justice.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04282356
Study Brief:
Protocol Section:
NCT04282356