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Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

Primary Purpose

Malignant Neoplasm of Stomach

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

intraperitoneal chemoperfusion

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Stomach focused on measuring gastric cancer, intraperitoneal chemoperfusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG.
No evidence of distant metastases
preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage
Written informed consent is obtained prior to commencement of trial treatment

Exclusion Criteria:

Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
Active systemic infections
Patients with known interstitial lung disease with New York Heart Association classification > 2
Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
cardiac arrhythmia
Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min
Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN
Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/
Active vaccination within 6 weeks prior to randomisation
Active hepatitis B or C infection
Female patients who are pregnant or breast feeding
Missing of capacity to contract
contraindication to the drugs which are used in the trial
Participation in another therapeutic clinical trial

Sites / Locations

Meng WangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

without HIPEC

with HIPEC

Arm Description

Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX).

Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group. Cisplatin: 75mg/m2 (max 150mg/m2 max 5L )

Outcomes

Primary Outcome Measures

overall survival

overall survival [ Time Frame: Death or 2 years ]

Secondary Outcome Measures

complication rate

time to progress

follow up every 3 months till 24 months end of study

time to distant metastasis

time to other distant metastases follow up every 3 months till 24 months

Full Information

NCT ID

NCT02381847

First Posted

February 28, 2015

Last Updated

March 4, 2015

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT02381847

Brief Title

Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

Official Title

Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

Detailed Description

The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A). The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival. The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

6. Conditions and Keywords

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

Malignant Neoplasm of Stomach

Keywords

gastric cancer, intraperitoneal chemoperfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

without HIPEC

Arm Type

No Intervention

Arm Description

Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX).

Arm Title

with HIPEC

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

intraperitoneal chemoperfusion

Other Intervention Name(s)

HIPEC

Intervention Description

HIPEC with cisplatin at the time of D2 radical surgery

Primary Outcome Measure Information:

Title

overall survival

Description

overall survival [ Time Frame: Death or 2 years ]

Time Frame

24 months

Secondary Outcome Measure Information:

Title

complication rate

Time Frame

30 days

Title

time to progress

Description

follow up every 3 months till 24 months end of study

Time Frame

24 months

Title

time to distant metastasis

Description

time to other distant metastases follow up every 3 months till 24 months

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG. No evidence of distant metastases preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage Written informed consent is obtained prior to commencement of trial treatment Exclusion Criteria: Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer Active systemic infections Patients with known interstitial lung disease with New York Heart Association classification > 2 Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure cardiac arrhythmia Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/ Active vaccination within 6 weeks prior to randomisation Active hepatitis B or C infection Female patients who are pregnant or breast feeding Missing of capacity to contract contraindication to the drugs which are used in the trial Participation in another therapeutic clinical trial

Central Contact Person:

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

Meng Wang

Phone

86-13815890469

wangmeng001@263.net

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

Wenxian Guan

Phone

86-83106666-60931

guan_wx@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenxian Guan

Organizational Affiliation

China Health Ministry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meng Wang

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng Wang

Phone

86-13815890469

wangmeng001@263.net

First Name & Middle Initial & Last Name & Degree

Wenxian Guan

Phone

86-25-83106666

guan_wx@163.com

First Name & Middle Initial & Last Name & Degree

Wenxian Guan, MD

First Name & Middle Initial & Last Name & Degree

Baorui Liu, MD

First Name & Middle Initial & Last Name & Degree

Meng Wang, MD

12. IPD Sharing Statement

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Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

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