NCT00992199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

2.2 years

First QC Date

October 8, 2009

Last Update Submit

September 7, 2010

Conditions

Advanced Gastric Cancer

Keywords

intraperitoneal chemotherapycisplatinfluorouraciladvanced gastric cancer

Outcome Measures

Primary Outcomes (1)

  • Metastasis in Peritoneum and peritoneal cavity

    1 year

Secondary Outcomes (3)

  • Liver metastasis

    1 year

  • Refraction-free survival

    1 year

  • Overall survival

    1 year

Study Arms (2)

control arm

NO INTERVENTION

adjuvant intravenous system chemotherapy

IP Chemo arm

EXPERIMENTAL

adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy

Drug: cisplatin, Fluorouracil

Interventions

cisplatin, FluorouracilDRUG

cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times

Also known as: DDP,5-Fu
IP Chemo arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS
  • Histologically confirmed primary adenocarcinoma of the stomach
  • weeks 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:
  • +14 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

CF regimen

Study Officials

  • Jin Li, MD

    member of Fudan University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li, MD

CONTACT

86(021)64175590fudanlijin@163.com

xiaodong Zhu, MD

CONTACT

86(021)64175590xddr001@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations

CN(1)