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Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer (IPchemo-AGC)

Primary Purpose

Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cisplatin, Fluorouracil
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Advanced Gastric Cancer focused on measuring intraperitoneal chemotherapy, cisplatin, fluorouracil, advanced gastric cancer

Eligibility Criteria

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

Inclusion Criteria:

DISEASE CHARACTERISTICS

  • Histologically confirmed primary adenocarcinoma of the stomach
  • 3-4weeks after radical operation for gastric cancer
  • Stage of the gastric cancer was T3-4NxM0

PATIENT CHARACTERISTICS:

  • Age: 18 - 70years old

Life expectancy:

  • Longer than 3 months

Hematopoietic:

  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 80*10^12/mm3

Hepatic:

- AST no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior chemotherapy and radiotherapy were not allowed
  • No other concurrent chemotherapy

Radiotherapy:

  • Locally radiotherapy for local disease of advanced gastric cancer during adjuvant treatment was allowed

Surgery:

  • See Disease Characteristics
  • Prior surgery for gastric cancer was necessary

Exclusion Criteria:

  • Haven't recovery from operation or complication of operation
  • With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
  • Pregnant or nursing
  • Other currently active malignancy except nonmelanoma skin cancer
  • Uncontrolled or severe bleeding,diarrhea,intestinal obstruction,adhesion of intestine
  • metastasis before enrollment
  • Received other chemotherapy or radiotherapy after operation

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control arm

IP Chemo arm

Arm Description

adjuvant intravenous system chemotherapy

adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy

Outcomes

Primary Outcome Measures

Metastasis in Peritoneum and peritoneal cavity

Secondary Outcome Measures

Liver metastasis
Refraction-free survival
Overall survival

Full Information

First Posted
October 8, 2009
Last Updated
September 7, 2010
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00992199
Brief Title
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
Acronym
IPchemo-AGC
Official Title
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions and contemporary chemotherapy, most patients attain better clinical remission.The majority of them, however, will eventually have a relapse and die of the disease. The peritoneal cavity is the principal site of disease in gastric cancer.Although the intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active drugs can be administered directly into the peritoneal cavity. The rationale for intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of tumor, receives sustained exposure to high concentrations of antitumor agents while normal tissues, such as the bone marrow, are relatively spared. The investigators conducted this trial to investigate the efficacy and safety of intraperitoneal chemotherapy in advanced gastric cancer.
Detailed Description
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
intraperitoneal chemotherapy, cisplatin, fluorouracil, advanced gastric cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control arm
Arm Type
No Intervention
Arm Description
adjuvant intravenous system chemotherapy
Arm Title
IP Chemo arm
Arm Type
Experimental
Arm Description
adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin, Fluorouracil
Other Intervention Name(s)
DDP,5-Fu
Intervention Description
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Primary Outcome Measure Information:
Title
Metastasis in Peritoneum and peritoneal cavity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Liver metastasis
Time Frame
1 year
Title
Refraction-free survival
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DISEASE CHARACTERISTICS Histologically confirmed primary adenocarcinoma of the stomach 3-4weeks after radical operation for gastric cancer Stage of the gastric cancer was T3-4NxM0 PATIENT CHARACTERISTICS: Age: 18 - 70years old Life expectancy: Longer than 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 80*10^12/mm3 Hepatic: - AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy and radiotherapy were not allowed No other concurrent chemotherapy Radiotherapy: Locally radiotherapy for local disease of advanced gastric cancer during adjuvant treatment was allowed Surgery: See Disease Characteristics Prior surgery for gastric cancer was necessary Exclusion Criteria: Haven't recovery from operation or complication of operation With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension) Pregnant or nursing Other currently active malignancy except nonmelanoma skin cancer Uncontrolled or severe bleeding,diarrhea,intestinal obstruction,adhesion of intestine metastasis before enrollment Received other chemotherapy or radiotherapy after operation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Li, MD
Phone
86(021)64175590
Ext
5108
Email
fudanlijin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiaodong Zhu, MD
Phone
86(021)64175590
Ext
5008
Email
xddr001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
Organizational Affiliation
member of Fudan University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
Phone
86(021)64175590
Ext
5108
Email
fudanlijin@163.com
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhu, MD
Phone
86(021)64175590
Ext
5008
Email
xddr001@163.com
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
First Name & Middle Initial & Last Name & Degree
Haiyi Guo, MD
First Name & Middle Initial & Last Name & Degree
xiaodnog Zhu, MD

12. IPD Sharing Statement

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Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

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