Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Wounds and Injuries

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Recurrence

Hyperthermia

Fever

Fallopian Tube Neoplasms

Peritoneal Neoplasms

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

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

secondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B). In some patients randomized to HIPEC at MSKCC only , peritoneal fluid and blood samples will be drawn before, during and after the HIPEC procedure.

secondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B).

Secondary Cytoreductive Surgery

Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

platinum-based systemic chemotherapy postoperatively

Dennis Chi, MD

The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer.

The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary peritoneal cancer.

Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Randomized Study: Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A proportion of patients ≥ 40%, who are without evidence of disease progression at 24 months, is considered acceptable, whereas a proportion of ≤ 25% is considered not acceptable in this patient population.

The safety endpoint of our trial is to determine toxicity and postoperative complication rates in both arms using NCI Common Terminology Criteria for Adverse Events version 4.0. and MSKCC Surgical Secondary Events Grading System for complications.

A secondary analysis of estimating the completion rate will be conducted. The completion rate and a 95% confidence interval will be calculated for each arm separately. Completion is defined as patients being able to complete ≥ 4 out of 5 or 6 cycles of a standard systemic chemotherapy.

in a subset of patients randomized to receive HIPEC in the OR. In patients randomized to HIPEC, peritoneal fluid and blood samples only from MSKCC patients will be drawn before, during and after the HIPEC procedure.

Mayo Clinic

Baptist Health South Florida

Hartford HealthCare

University of Pittsburgh

University of Chicago

Memorial Sloan Kettering Cancer Center

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Salvage Chemotherapy

Rongyu Zang, MD,PhD

The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.

The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer

Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first

the time of OS minus each treatment period after randomization, including surgery and chemotherapy

OS adjusted by statistical models for crossover

MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications

iMODEL score to predict complete resection

The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)

From date of randomization until the date of first recurrent anticancer therapy

From date of randomization until the date of secondary recurrent anticancer therapy

Fudan University

Zhejiang Cancer Hospital

Shanghai Zhongshan Hospital

Sun Yat-sen University

Shanghai Gynecologic Oncology Group

Disease Progression

Herbal and Botanical

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Doxorubicin

Liposomal doxorubicin

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Mango

Olaparib 300 mg, film-coated tablets, twice daily PO, d1- 28 continuously

Platinum-based chemotherapy at the Investigator's choice among the following regimens:

* Carboplatin (AUC5) plus Pegylated Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 every 28 days for a maximum of 8 cycles;
* Carboplatin (AUC4) plus Gemcitabine 1000mg/m2 on day 1, 8 every 21 days for a maximum of 8 cycles;
* Carboplatin (AUC5) plus Paclitaxel (175mg/m2) every 21days for a maximum of 8 cycles

Chemotherapy drug

Clorinda Schettino, MD

Sandro Pignata, MD

Sandro Pignata, MD, PhD

MITO 35b is designed as randomized, open label, phase III trial that aims to assess the efficacy of olaparib maintenance beyond progression compered to standard platinum-based chemotherapy after secondary cytoreductive surgery.

The target population of this study are ovarian cancer patients who experience a disease recurrence or progression to a first line maintenance therapy with PARPi; at progression patients must have received a secondary cytoreduction according to clinical practice.

MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.

Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. The Phase III Randomized, Open Label MITO 35b Study: a Project of the MITO-MANGO Groups.

PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to progression or death for any cause,whichever comes first

PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to second progression or death for any cause

OS as defined by the Investigator as the time from randomization to death for any cause, whichever comes first.

EORTC QLQ-C30, a quality questionnaire, composed by 30 items graded from 1 (not at all) to 4 (very much).

PRO-CTCAE questionnaire, composed by 78 items graded from 1 (not at all) to 5 (very much).

The PROFFITquestionnaire consists of 16 items,graded from 1 (not at all) to 4 (very much).

Number of participants with treatment-related side effects

Number of participants with treatment-related side effects graded according to Common Criteria for Adverse Events (CTCAE) version 5.0

National Cancer Institute, Naples

Anti-Infective Agents

Niraparib

Cisplatin

Taxane

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Intervention:

Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib

Intervention: Drug: Platinum-based chemotherapy and Niraparib

Tumor debulking surgery (surgery in recurrent ovarian disease)

Surgery

carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...

Rong Jiang, M.D.

Yuting Luan, R.N.

Rong Jiang, MD

Yuting Luan, RN

Yanling Feng

Wen Gao

Wei Jiang

Wei Bao

Tingyan Shi, M.D., Ph.D.

Rongyu Zang, M.D., Ph.D.

This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.

This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer.

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer

from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)

It is the area between Kaplan-Meier curves for two time-to-event end points: 1) time to protocol chemotherapy cessation and 2) time to first subsequent anticancer therapy initiation or death, whichever occurred first.

from date of randomization until the date of death from any cause

surgical complications grading criteria will be adopted for evaluating the perioperative complications

the European Organization for Research and Treatment (EORTC) core quality of life questionnaire (QLQ-C30, version 3.0) The total score (range from 0 to 1,000)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT01767675	Ovarian Cancer Fallopian Tubes... Peritoneal Canc...	Secondary Cytor... Carboplatin Hyp... platinum-based ... platinum-based ...	21 Years -	Memorial Sloan Kettering Cancer Center
Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?	NCT01611766	Ovarian Epithel... Fallopian Tube ... Primary Periton...	Secondary Cytor... Salvage Chemoth...	18 Years - 80 Years	Shanghai Gynecologic Oncology Group
Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT01767675	Ovarian Cancer Fallopian Tubes... Peritoneal Canc...	Secondary Cytor... Carboplatin Hyp... platinum-based ... platinum-based ...	21 Years -	Memorial Sloan Kettering Cancer Center
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.	NCT05255471	Ovarian Cancer	Olaparib Chemotherapy dr...	18 Years -	National Cancer Institute, Naples
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)	NCT03983226	Ovarian Cancer ... Fallopian Tube ... Primary Periton...	Surgery carboplatin/tax... Niraparib	18 Years - 75 Years	Shanghai Gynecologic Oncology Group

Spots Global Cancer Trial Database for secondary cytoreductive surgery