Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

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

Ovarian Cancer

Ovarian Epithelial Cancer

* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
* Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV.
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site

MRI-guided SBRT

30 questions with 28 questions having answers that range from 1 (not at all) to 4 (very much) and the other 2 questions have answers that range from 1 (very poor) to 7 (excellent)

EORTC QLQ-C30 Questionnaire

28 questions having answers that range from 1 (not at all) to 4 (very much)

EORTC QLQ-OV28 Questionnaire

Clifford Robinson, M.D.

The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treatment machine. To best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. The prescription dose will be determined based on hard normal tissue constraints, and capped at 10Gy per fraction. Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.

MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer

Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer

the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

-Response will be measured using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\].

-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

-The length of time that a patient survives without any signs or symptoms of their cancer

* HRQOL will be measured using the EORTC QLQ-C30 and QLQ-OV28 questionnaires.
* European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 consists of 28 questions with answers that range from 1 (Not At All) to 4 (Very Much) and 2 questions that range from 1 (Very Poor) to 7 (Excellent)
* EORTC QLQ-OV28 consists of 28 questions ranging with answers from 1 (Not At All) to 4 (Very Much)

Washington University School of Medicine

Skin and Connective Tissue Diseases

Breast Neoplasms

Endometrial Neoplasms

Breast Diseases

Skin Diseases

Uterine Neoplasms

Uterine Diseases

PF-07260437

B7-H4 IHC

Pfizer CT.gov Call Center

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.

A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07260437 IN ADVANCED OR METASTATIC SOLID TUMORS

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

DLTs will be evaluated in Part 1. The number of DLTs will be used to determine the dose escalation decision and recommended dose of PF-07260437

DOR as assessed using RECIST 1.1 and irRECIST

TTP as assessed using RECIST 1.1 and irRECIST

ORR as assessed using RECIST 1.1 and irRECIST

PFS as assessed using RECIST 1.1 and irRECIST

Immune Cells assessments from paired biopsies

Pfizer

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

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

Neoplasm Metastasis

Recurrence

Neoplastic Processes

Dermatologic Agents

Immune Checkpoint Inhibitors

Immunomodulating Agents

Coal Tar

Keratolytic Agents

Group A (drug treatment group) : Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.

IFRT, IMRT or SBRT is applied. Irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent.

Drug therapy is the same as group A; IFRT is the same as group B.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer	NCT02582931	Cancer of Ovary Cancer of the O... Neoplasms, Ovar... Ovarian Cancer Ovary Cancer Ovary Neoplasms	MRI-guided SBRT EORTC QLQ-C30 Q... EORTC QLQ-OV28 ...	18 Years -	Washington University School of Medicine
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors	NCT05067972	Ovarian Neoplas... Endometrial Neo... Breast Neoplasm...	PF-07260437 B7-H4 IHC	18 Years -	Pfizer
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)	NCT03842982	Ovary Neoplasms Ovarian Cancer Ovarian Carcino...	HIPEC	18 Years - 76 Years	Centre Oscar Lambret
Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer	NCT05059782	Ovarian Cancer Neoplasm, Ovari... Ovarian Neoplas... Ovary Neoplasms Neoplasm, Ovary Neoplasms, Ovar... Ovary Neoplasm Neoplasms, Ovar... Ovary Cancer Cancer, Ovarian... Cancers, Ovary Ovary Cancers Cancer, Ovarian Cancers, Ovaria... Ovarian Cancers Cancer of Ovary Cancer of the O...	chemotherapy, t... IFRT, IMRT or S...	18 Years -	Health Science Center of Xi'an Jiaotong University
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines	NCT02432378	Cancer of Ovary Cancer of the O... Neoplasms, Ovar... Ovarian Cancer Ovary Cancer Ovary Neoplasms	Cisplatin + cel... Cisplatin + CKM...	18 Years -	Roswell Park Cancer Institute
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors	NCT05067972	Ovarian Neoplas... Endometrial Neo... Breast Neoplasm...	PF-07260437 B7-H4 IHC	18 Years -	Pfizer

Spots Global Cancer Trial Database for ovary neoplasms