Intensive intraperitoneal therapy in advanced ovarian cancer combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC).

Intensive intraperitoneal therapy in advanced ovarian cancer combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC). - INTENS-IP

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003357-29-FR

Enrollment

Registered

2019-10-21

Start date

2019-12-03

Completion date

Unknown

Last updated

2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient 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

Interventions

Trade Name: CISPLATIN Pharmaceutical Form: Solution for injection Trade Name: PACLITAXEL Pharmaceutical Form: Solution for injection Trade Name: CARBOPLATINE Pharmaceutical Form: Solution for inject

Eligibility

Sex/Gender

All

Inclusion 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, - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: - Performance Index (WHO) = 2, - Stage IV B or IV A with significant pleural effusion, - Renal impairment (clearance 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the success including both feasibility and tolerance of the HIPEC and CIP combination after a complete interval tumor reduction surgery in 1st-line treatment of stages B-C and IV A ovarian cancers, with minimal or moderate pleural effusion;Secondary Objective: -To evaluate the morbidity and renal toxicity of hyperthermic intraperitoneal chemotherapy (HIPEC) in first-line treatment of advanced ovarian cancer patients receiving an interval surgery after 3 to 4 cycles of CNA, -To evaluate the toxicity (mainly digestive and renal) of intraperitoneal postoperative chemotherapy (IPC) after performing HIPEC. -To assess the number of intraperitoneal chemotherapy courses administered after HIPEC realization. -To assess the therapeutic efficacy of the combination of HIPEC and IPC. -To evaluate the patients' quality of life.;Primary end point(s): The success of the combination of HIPEC and IPC will be evaluated with two co-primary endpoints: the feasibility rate and the toxicity rate. -Feasibility of HIPEC and IPC combination will be defined by the administration of at least 3 courses of intraperitoneal chemotherapy during the 6 months following complete interval cytoreductive surgery with HIPEC. ? Feasibility endpoint will be evaluated 6 months after interval surgery with HIPEC. -Safety will be assessed by the surveillance of the following criteria: oHIPEC tolerance: ?Significant deterioration of the renal function (reduction of creatinine clearance > 20%, assessed before and 15 days following interval surgery) ?A delayed start of chemotherapy > 60 days after surgery (reflecting surgical complications) oCIP Tolerance : major side-effects requiring IP treatment discontinuation before 3 adjuvant IP cycles : ?Abdominal pain (grade 3) requiring treatment discontinuation before the 3 IP cycles, ?Severe complications of the IP treatment: catheter removal, intestinal perforation, intestinal obstruction, chemical peritonitis. ? HIPEC tolerance wil	—

Measure

Time frame

Main Objective: To evaluate the success including both feasibility and tolerance of the HIPEC and CIP combination after a complete interval tumor reduction surgery in 1st-line treatment of stages B-C and IV A ovarian cancers, with minimal or moderate pleural effusion;Secondary Objective: -To evaluate the morbidity and renal toxicity of hyperthermic intraperitoneal chemotherapy (HIPEC) in first-line treatment of advanced ovarian cancer patients receiving an interval surgery after 3 to 4 cycles of CNA, -To evaluate the toxicity (mainly digestive and renal) of intraperitoneal postoperative chemotherapy (IPC) after performing HIPEC. -To assess the number of intraperitoneal chemotherapy courses administered after HIPEC realization. -To assess the therapeutic efficacy of the combination of HIPEC and IPC. -To evaluate the patients' quality of life.;Primary end point(s): The success of the combination of HIPEC and IPC will be evaluated with two co-primary endpoints: the feasibility rate and the toxicity rate. -Feasibility of HIPEC and IPC combination will be defined by the administration of at least 3 courses of intraperitoneal chemotherapy during the 6 months following complete interval cytoreductive surgery with HIPEC. ? Feasibility endpoint will be evaluated 6 months after interval surgery with HIPEC. -Safety will be assessed by the surveillance of the following criteria: oHIPEC tolerance: ?Significant deterioration of the renal function (reduction of creatinine clearance > 20%, assessed before and 15 days following interval surgery) ?A delayed start of chemotherapy > 60 days after surgery (reflecting surgical complications) oCIP Tolerance : major side-effects requiring IP treatment discontinuation before 3 adjuvant IP cycles : ?Abdominal pain (grade 3) requiring treatment discontinuation before the 3 IP cycles, ?Severe complications of the IP treatment: catheter removal, intestinal perforation, intestinal obstruction, chemical peritonitis. ? HIPEC tolerance wil

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Secondary

Measure	Time frame
Secondary end point(s): - Morbidity of reductive surgery combined with HIPEC assessed up to 60 postoperative days, according to the CLAVIEN and DINDO score, - HIPEC toxicities reported according to the CTC-AE v5.0 scale, especially renal toxicities, - Period of time between HIPEC and the first IPC course, - IPC toxicities reported according to the CTC-AE v5.0 scale, especially renal toxicities, - Complications due to intraperitoneal catheters (obstruction, infection, deposition, occlusion) after interval surgery with HIPEC. - Number of IPC courses administered after interval surgery with HIPEC. - Relapse-Free survival, - Time up to peritoneal recurrence, - Overall survival, Quality of life questionnaire (QLQ-C30 & QLQ-OV28). ;Timepoint(s) of evaluation of this end point: -Morbidity is assessed up to 60 postoperative days, according to the CLAVIEN and DINDO score, -HIPEC toxicities are reported according to the CTC-AE v5.0 scale -Period of time between HIPEC and the first IPC course, -IPC toxicities reported according to the CTC-AE v5.0 scale -Complications after interval surgery with HIPEC. -Number of IPC courses administered after interval surgery with HIPEC. -Relapse-Free survival is defined from the date of inclusion to the date of death -peritoneal recurrence is defined from the date of inclusion to the date of recurrence, -Overall survival is defined from the date of inclusion to the date of death, - QLQ-C30 & QLQ-OV28 at baseline, 30 days post operative, 3 months, 12 months and 24 months post surgery.	—

Measure

Time frame

Secondary end point(s): - Morbidity of reductive surgery combined with HIPEC assessed up to 60 postoperative days, according to the CLAVIEN and DINDO score, - HIPEC toxicities reported according to the CTC-AE v5.0 scale, especially renal toxicities, - Period of time between HIPEC and the first IPC course, - IPC toxicities reported according to the CTC-AE v5.0 scale, especially renal toxicities, - Complications due to intraperitoneal catheters (obstruction, infection, deposition, occlusion) after interval surgery with HIPEC. - Number of IPC courses administered after interval surgery with HIPEC. - Relapse-Free survival, - Time up to peritoneal recurrence, - Overall survival, Quality of life questionnaire (QLQ-C30 & QLQ-OV28). ;Timepoint(s) of evaluation of this end point: -Morbidity is assessed up to 60 postoperative days, according to the CLAVIEN and DINDO score, -HIPEC toxicities are reported according to the CTC-AE v5.0 scale -Period of time between HIPEC and the first IPC course, -IPC toxicities reported according to the CTC-AE v5.0 scale -Complications after interval surgery with HIPEC. -Number of IPC courses administered after interval surgery with HIPEC. -Relapse-Free survival is defined from the date of inclusion to the date of death -peritoneal recurrence is defined from the date of inclusion to the date of recurrence, -Overall survival is defined from the date of inclusion to the date of death, - QLQ-C30 & QLQ-OV28 at baseline, 30 days post operative, 3 months, 12 months and 24 months post surgery.

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Countries

France

Contacts

Public ContactDr Jean-Pierre BLEUSE

Institut Régional Du Cancer de Montpellier (ICM)

drci-icm105@icm.unicancer.fr0033467613102

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026