Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperthermia

Fever

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bevacizumab

Cisplatin

Sodium thiosulfate

Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy (standard care) + HIPEC (hyperthermic intraperitoneal chemotherapy)

Patients in this experimental arm will receive surgery (either PDS or IDS) and Neo and/or Adjuvant chemotherapy (CT) (as per standard care) combined with HIPEC. Patients undergoing PDS will also be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery).

Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care.

Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy ONLY (standard care, without HIPEC)

Patients in the control group will ONLY receive the standard care, which consists of surgery (PDS or IDS) with Neo and/or Adjuvant chemotherapy (CT). Patients undergoing PDS will be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery).

Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care.

HIPEC protocol (ONLY Arm A) consisted in cisplatin 100mg/m2 intraperitoneally (IP), heated to 40°C for 90 minutes, along with an IV perfusion of sodium thiosulfate.

Administration of the dose should be according the following schedule:

* 50% of the dose at start of perfusion, 25% of the dose after 30 minutes from start of the perfusion and 25% of the dose after 60 minutes from start of the perfusion.
* The procedure takes 120 minutes with a 90-minute perfusion period. The IV perfusion of sodium thiosulfate is for renal protection. At the start of HIPEC procedure, 9 g/m2 in 200 ml of distilled water will be administered by IV over 15 to 30 minutes. It will be then followed by 12 g/m2 in 1 liter (1L) distilled water in a continuous IV for 6 hours.

HIPEC

Marie VANSEYMORTIER

Fabrice MULOT

Florence FONTAINE

Karoline AMANN

Romuald WERNERT, MD

Pedro RARO, MD

Valeria DE FRANCO, MD

Augustin REYNARD, MD

Patrick SOULIE, MD

Sophie ABADIE-LACOURTOISIE, MD

Paule AUGEREAU, MD

Anne PATSOURIS, MD

Elouen BOUGHALEM, MD

Frédéric BIGOT, MD

Margot NOBLECOURT, MD

Victor SIMMET, MD

Marion DE VRIES, MD

Coriolan LEBRETON

Sandrine MARTIN-FRANCOISE, MD

Jean François LE BRUN, MD

Florence JOLY, MD

Emeline MERIAUX, MD

Christophe POMEL, MD

Caroline CORNOU, MD

Sophie DUBOIS, MD

Morgane MASSON, MD

Marie-Ange MOURET-REYNIER, MD

Fabrice NARDUCCI, MD

Delphine HUDRY, MD

Eric LEBLANC, MD

Cyril ABDEDDAIM, MD

Annick CHEVALIER-PLACE, MD

Alfred BASSIL, MD

Charlotte BELLIER, MD

Valérie CHEVALIER-EVAIN, MD

Emilie KACZMAREK, MD

Samira MAKHLOUFI, MD

Pierre COLLINET, MD, PhD

Clarisse EVENO, MD

Jérôme PHALIPPOU, MD

Christophe DESAUW, MD

Anne PLOQUIN, MD

Eric LAMBAUDIE, MD, PhD

Gilles HOUVENAEGHEL, MD

Guillaume BLACHE, MD

Laura SABIANI, MD

Julien BARROU, MD

Maria Antonietta CAPPIELLO, MD

Magali PROVANSAL, MD

Frédérique ROUSSEAU, MD

Renaud SABATIER, MD

Pierre-Emmanuel COLOMBO, MD

Sébastien CARRERE, MD

Anne MOURREGOT, MD

François QUENET, MD

Philippe ROUANET, MD

Olivia SGARBURA, MD

Véronique D'HONDT, MD

Michel FABBRO, MD

Anne-Sophie BATS, MD

Nicolas DELANOY, MD

Henri AZAIS, MD

Enrica BENTIVEGNA, MD

Meriem KOUAL, MD

Huyên-Thu NGUYEN-XUAN, MD

Naoual BAKRIN, MD

Witold GERTYCH, MD

Olivier GLEHEN, MD

Vahan KEPENEKIAN, MD

Benoit YOU, MD

Pierre DESCARGUES, MD

Pierre-Adrien BOLZE, MD

Benoît RESCH, MD

Benoït RESCH, MD

Marc BARON, MD

Julien COGET, MD

Clotilde HENNETIER, MD

Morgane PERRIN, MD

Jean Jacques TUECH, MD

Alexandre MARQUE, MD

Sandrine MEZZANI, MD

Cécile HENNEBERT, MD

Agathe CROUZET, MD

Julien CARRILHO, MD

Emmanuel DE GOURNAY, MD

Albane POTEAU, MD

Laetitia AUGUSTO, MD

Sophie GOUERANT, MD

Cécile GUILLEMET, MD

Marianne LEHEURTEUR, MD

Camille PETRAU, MD

Chérif AKLADIOS, MD

Thomas BOISRAME, MD

Lauriane EBERST, MD

Frédéric MARCHAL, MD

Yolanda FERNANDEZ DIEZ, MD

Céline GAVOILLE, MD

Marie-Christine KAMINSKY, MD

Cécilia CERIBELLI, MD

This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.

The primary objective of this study is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone).

Secondary objectives of the study include:

* Evaluating the efficacy of HIPEC in terms of overall survival (OS) in combination with standard of care
* Evaluating the morbidity associated with HIPEC.
* Evaluating the trade-off between efficacy and morbidity using the Q-TWiST approach.
* Evaluating the impact of HIPEC in terms of quality of life.

Exploratory objectives (optional) include:

* Evaluating the impact of HIPEC on the count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids for patients recruited in Centre Oscar Lambret only.
* Constituting a biobank (tumoral samples and blood samples) for future translational researches

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)

Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)

The DFS will be measured to assess the efficacy of the combination treatment of surgery and HIPEC or standard care alone.

The overall survival will be measured to assess the efficacy of HIPEC in combination with standard care.

The adverse events (AE) are collected to evaluate the impact of HIPEC on the safety and on the feasibility of adjuvant treatment (if any) is planned after surgery.

Q-Twist (Quality-adjusted time without symptoms of disease or toxicity) will be calculated from the survival tile (OS and DFS) and AE (adverse events) data.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30) will be used to measure the quality of life of the patients.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28) will be used to measure the quality of life of the patients.

Centre Oscar Lambret

Fallopian Tube Neoplasms

Fallopian Tube Diseases

Fallopian Tube Cancer

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Paclitaxel

Carboplatin

Niraparib

Docetaxel

Albumin-Bound Paclitaxel

Adenosine

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy.

Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy.

Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.

Primary debulking surgery

3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.

Neoadjuvant chemotherapy

For patients with CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors. In this trial, Niraparib 200mg po qd is suggested after the front-line therapy.

PARP inhibitor

Libing Xiang

Rong Jiang

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.

Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

The proportion of patients alive at 3 years after entry into the study

Time from entry into the study to any cause of death

Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first

The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery

QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)

Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy)

Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first

Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first

The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.

Fudan University

Shanghai Gynecologic Oncology Group

Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)	NCT03842982	Ovary Neoplasms Ovarian Cancer Ovarian Carcino...	HIPEC	18 Years - 76 Years	Centre Oscar Lambret
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer	NCT05200260	Ovarian Cancer Fallopian Tube ... Primary Periton...	Primary debulki... Neoadjuvant che... PARP inhibitor	18 Years -	Shanghai Gynecologic Oncology Group
Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)	NCT04515602	Epithelial Ovar... Fallopian Tube ... Primary Periton...	Primary debulki... Neoadjuvant che... PARPi	18 Years -	Shanghai Gynecologic Oncology Group

Spots Global Cancer Trial Database for primary debulking surgery