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

Primary Purpose

Gastric Cancer, Peritoneal Carcinomatosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

HIPEC with neoadjuvant chemotherapy

Systemic chemotherapy

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Peritoneal Carcinomatosis, Hyperthermic Intraperitoneal Chemotherapy, Systemic Chemotherapy, Cytoreductive Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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 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 Cytoreductive surgery HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession 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

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 Cytoreductive surgery 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

Outcomes

Primary Outcome Measures

Median overall survival

assess median overall survival rate during 3 years in both study arms

Secondary Outcome Measures

Risk factors for morbidity and mortality

determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).

Full Information

NCT ID

NCT03179579

First Posted

June 6, 2017

Last Updated

June 6, 2017

Sponsor

Shu-Zhong Cui

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03179579

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2017 (Anticipated)

Primary Completion Date

August 1, 2021 (Anticipated)

Study Completion Date

August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shu-Zhong Cui

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Peritoneal Carcinomatosis

Keywords

Gastric Cancer, Peritoneal Carcinomatosis, Hyperthermic Intraperitoneal Chemotherapy, Systemic Chemotherapy, Cytoreductive Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

HIPEC with neoadjuvant chemotherapy

Other Intervention Name(s)

CRS with HIPEC and adjuvant cheomtherapy

Intervention Description

HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles

Intervention Type

Procedure

Intervention Name(s)

Systemic chemotherapy

Other Intervention Name(s)

CRS with systemic chemotherpay

Intervention Description

NACT 3 cycles +CRS +ACT 4-6 cycles

Primary Outcome Measure Information:

Title

Median overall survival

Description

assess median overall survival rate during 3 years in both study arms

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Risk factors for morbidity and mortality

Description

determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).

Time Frame

Through study completion, an average of 1 year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gastic adenocarcinoma is diagnosed by histological and cytological examination. Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration. According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20. 18 < Age < 70 year old Expected survival > 3 months Performance status: ECOG 0-1 Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3 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: Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs. Extensive adhesion in peritoneal cavity Previous History of other malignancies Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50% Receiving other chemotherapy, radiotherapy or immunotherapy Patients who are unsuitable candidates by doctor's decision Without given written informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xian-Zi Yang, M.D

Phone

8602066673666

7097359@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen Tang, M.M

Phone

8602066673666

tangzhentangmin@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shu-Zhong Cui, M.D

Organizational Affiliation

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510095

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianzi Yang, M.D

Phone

8602066673666

7097359@qq.com

First Name & Middle Initial & Last Name & Degree

shuzhong cui, M.D

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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