Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer

June 6, 2017 updated by: Shu-Zhong Cui

A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Systemic Chemotherapy And Cytoreductive Surgery (CRS) in the Treatment of Peritoneal Carcinomatosis From Gastric Cancer

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xian-Zi Yang, M.D
  • Phone Number: 8602066673666
  • Email: 7097359@qq.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gastic adenocarcinoma is diagnosed by histological and cytological examination.
  2. Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
  3. According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.
  4. 18 < Age < 70 year old
  5. Expected survival > 3 months
  6. Performance status: ECOG 0-1
  7. Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3
  8. Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN

10. Voluntary participation after getting written informed consent.

Exclusion Criteria:

  1. Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
  2. Extensive adhesion in peritoneal cavity
  3. Previous History of other malignancies
  4. Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
  5. Receiving other chemotherapy, radiotherapy or immunotherapy
  6. Patients who are unsuitable candidates by doctor's decision
  7. Without given written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
  1. HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession
  2. 2 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks
  3. Cytoreductive surgery
  4. HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession
  5. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks
Procedure: HIPEC with neoadjuvant chemotherapy
HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles
Other Names:
  • CRS with HIPEC and adjuvant cheomtherapy
Active Comparator: Control group
  1. 3 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks
  2. Cytoreductive surgery
  3. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks
Procedure: Systemic chemotherapy
NACT 3 cycles +CRS +ACT 4-6 cycles
Other Names:
  • CRS with systemic chemotherpay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median overall survival
Time Frame: 3 years
assess median overall survival rate during 3 years in both study arms
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for morbidity and mortality
Time Frame: Through study completion, an average of 1 year.
determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shu-Zhong Cui

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine
Chinese PLA General Hospital
Tianjin Medical University Cancer Institute and Hospital
Guangdong Provincial People's Hospital
Southern Medical University, China
Harbin Medical University

Investigators

  • Study Chair: Shu-Zhong Cui, M.D, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPEC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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