Symptoms and General Pathology

All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Wounds and Injuries

Behaviors and Mental Disorders

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Recurrence

Ovarian Neoplasms

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Hyperthermia

Fever

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Ovarian Diseases

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.

Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

CRS+HIPEC

Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.

CRS alone

Hongbing Cai, Doctor

Zhen Li, Doctor

Yuanzhen Zhang, Doctor

A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.

A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes

The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.

The overall survival interval was the time between diagnosis and death or last follow-up.

The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis.

The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis.

Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0

CAI Hongbing

Dr. Prof.

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Peritoneal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Abdominal Neoplasms

Peritoneal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bevacizumab

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Mitomycins

Mitomycin

6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.

Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev

6 cycles of mFOLFOXIRI±Bev is administrated before CRS+HIPEC. Irinotecan165mg/m2 IV day 1, oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted. Bev will not be administrated in at the last two cycles for minimizing surgery complications.

Preoperative systematic therapy

CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.

6 cycles of mFOLFOX+Bev is administrated after CRS+HIPEC. Oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2 IV bolus day 1,5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted.

Postoperative chemotherapy

12 cycles of mFOLFOX+Bev is administrated after CRS+HIPEC. Oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2 IV bolus day 1,5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted.

Hui Wang, MD

Huaiming Wang

Hui Wang

This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.

Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial

Participant-level raw data will not publically available unless reasonable request.

From randomization to progression by RECIST1.1, or appearance of measurable lesion after non-measureable lesion, or intraoperative unresectable disease, or recurrence after surgery, or death from any reason.

Peritoneal cancer index (PCI) is a tool which sum scores in thirteen abdominal regions according to tumor size.

Sun Yat-sen University

Director

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

1. Ib

   * Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure.
2. II

   ① CRS If PCI \<12, CRS will be performed by gastrectomy with D2-lymphadenectomy and resection of any involved adjacent structures.

   If PCI≥12, instead of CRS, 3 times of IP paclitaxel +cisplatin and oral S-1 chemotherapy every 3 weeks, and then PCI \<12, CRS will be done.

   ② Extensiveintraperitoneal lavage Peritoneal lavage after CRS will be done with 10 L before HIPEC.

   ③ HIPEC Following surgery HIPEC will be performed using CDDP (60 mg/m2) and PTX (P2RD mg/m2). IP chemotherapy will be performed.

   ④ Post-operative intraperitoneal chemotherapy Postoperative chemotherapy will be done 8 cycles of IP paclitaxel+ cisplatin and oral S-1 after 4 weeks.

This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy combination in gastric cancer with peritoneal metastasis

Peritoneal metastases in gastric cancer are considered to indicate terminal disease due to poor prognosis because systemic chemotherapy is unlikely to accumulate in peritoneal nodules in cytotoxic concentrations. Cytoreductive surgery (CRS) along with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in select patients with limited peritoneal spread, resulting in a median overall survival (OS) of 8 to 14 months. It remains unclear, however, which regimen is best and who have benefits from CRS and HIPEC. Herein, we has conducting prospective phase Ib/II trial of CRC and HIPEC with intraperitoneal paclitaxel and cisplatin, and oral S-1 in gastric cancer with peritoneal metastasis.

A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis

Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.

II:To assess the safety and tolerability of CRS +HIPEC (Clavien-Dindo classification of surgical complication \& NCI-common terminology criteria for adverse events(CTC-AE) for chemotherapy\]

the length of time from the patient signing the consent form until the patient is still alive

the length of time from the patient signing the consent form until the patient shows disease progression

the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases	NCT05353582	Colorectal Neop... Colorectal Canc... Colorectal Canc... Peritoneal Meta... Peritoneal Canc... Peritoneal Neop... Chemotherapy Ef... Cytoreductive S... Hyperthermic In...	Preoperative sy... CRS+HIPEC Postoperative c... Postoperative c...	18 Years - 75 Years	Sun Yat-sen University
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation	NCT04473339	Ovarian Cancer Epithelial Ovar... Ovarian Cancer,... Hyperthermic In... Homologous Reco...	CRS+HIPEC CRS alone	18 Years - 75 Years	Zhongnan Hospital
A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis	NCT02995850	Gastric Cancer ...	CRS+HIPEC	19 Years -	Yonsei University
A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis	NCT02995850	Gastric Cancer ...	CRS+HIPEC	19 Years -	Yonsei University

Spots Global Cancer Trial Database for crs+hipec

Every month we try and update this database with for crs+hipec cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for crs+hipec

Every month we try and update this database with for crs+hipec cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crs+hipec cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.