cisplatin for Ovarian epithelial cancer (intraperitoneal resectable relapse)

Inclusion criteria

• {"criterion_text":"- Patient age ≥ 18 years,\n- Hematological functions : PNN > ou = 1.5x109/L, platelets > ou = 100x109/L,\n- No contraindication to general anesthesia for heavy surgery\n- Patient must be informed and the Informed Consent Form signed before any study-specific procedures start.\n- Medical/Public Health insurance coverage\n- Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.\n- Performance Status WHO < 2,\n- Previous treatment for epithelial ovarian cancer, tubal peritoneal primitive\n- 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)\n- Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)\n- Complete cytoreductive surgery,\n- Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 weeks\n- No hepatic insufficiency (bilirubin ≤ 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT ≤ 3 ULN,\n- No renal insufficiency (creatinine ≤ 1.5 ULN, creatinine clearance >60 ml/min) calculated with MDRD method,"}

Exclusion criteria

• {"criterion_text":"- Patient age <18 years,\n- Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),\n- Known hypersensitivity to cisplatin,\n- Metastasis,\n- Use of anti-angiogenic treatment within 8 weeks before surgery\n- Patient with other concomitant severe life threatening disease,\n- More than 2 segmental resections concomitant to HIPEC is foreseen,\n- Any progressive disease during the second-line chemotherapy (platine-based),\n- Relapse occurring less than 6 months after the end of the initial treatment,\n- Non-epithelial ovarian tumor,\n- Uncontrolled infection,\n- Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.\n- Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,\n- Patient who has already been treated by HIPEC for ovarian cancer,\n- Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,\n- Pregnant or breastfeeding woman\n- Patient who has already been enrolled in another clinical trial"}

Primary endpoints

• {"endpoint_text":"- The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.","definition_or_measurement_approach":"Overall survival measured by the date of death (date of death, whatever its cause, is the main parameter used to evaluate overall survival)."}

Secondary endpoints

• {"endpoint_text":"- Relapse-free Survival : Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytological diagnostic), biological criteria (confirmed elevation of CA 125 markers according to RUSTIN criteria) or medical imaging criteria (detection of measurable mass, with the new RECIST criteria). The main criteria will be the date at which relapse occurrence is detected.","definition_or_measurement_approach":"Relapse defined by clinical (mass or effusion with cytology), biological (confirmed CA125 elevation per RUSTIN) or imaging (measurable mass per RECIST). Endpoint measured as date of relapse occurrence."}
• {"endpoint_text":"- Pain and Quality of Life : Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer). Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis.","definition_or_measurement_approach":"QoL measured using EORTC QLQ-C30 and FACT-O; pain measured by Visual Analogue Scale (VAS); chronic pain history recorded and adjusted for in analysis."}
• {"endpoint_text":"- Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale","definition_or_measurement_approach":"Treatment toxicity graded using CTCAE (CTC-AE) v4.0, with particular attention to renal toxicity."}
• {"endpoint_text":"- Morbidity : Morbidity evaluation will be performed until the 60th day after surgery, taking into account: - deaths - severe complications","definition_or_measurement_approach":"Morbidity evaluated up to 60 days post-surgery, including deaths and severe complications."}
• {"endpoint_text":"- Medico-economic study: collection of socio-demographical data and patient management costs.","definition_or_measurement_approach":"Collection of socio-demographic data and patient-related management costs for medico-economic analysis."}
• {"endpoint_text":"- Pharmacokinetic study: on 50 patients included who received HIPEC (25 in the open method and 25 in the closed method: Analysis of platinum concentrations at the peritoneal, plasma and tissue levels.","definition_or_measurement_approach":"Pharmacokinetic analysis of platinum concentrations at peritoneal, plasma and tissue levels in 50 HIPEC patients (25 open method, 25 closed method)."}

France

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

25-09-2024

Processing Time Days

37

Number Of Sites

26

Number Of Participants

383

Primary sponsor

Full Name

Unicancer

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France