Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer (IPchemo-AGC)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Gastric Cancer |
Drug: cisplatin, Fluorouracil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer |
- Metastasis in Peritoneum and peritoneal cavity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Liver metastasis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Refraction-free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 79 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control arm
adjuvant intravenous system chemotherapy
|
|
|
Experimental: IP Chemo arm
adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy
|
Drug: cisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Other Name: DDP,5-Fu
|
Detailed Description:
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jin Li, MD | 86(021)64175590 ext 5108 | fudanlijin@163.com |
| Contact: xiaodong Zhu, MD | 86(021)64175590 ext 5008 | xddr001@163.com |
| China, Shanghai | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Jin Li, MD 86(021)64175590 ext 5108 fudanlijin@163.com | |
| Contact: Xiaodong Zhu, MD 86(021)64175590 ext 5008 xddr001@163.com | |
| Principal Investigator: Jin Li, MD | |
| Sub-Investigator: Haiyi Guo, MD | |
| Sub-Investigator: xiaodnog Zhu, MD | |
| Principal Investigator: | Jin Li, MD | member of Fudan University Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Haiyi Guo, Fudan University Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT00992199 History of Changes |
| Other Study ID Numbers: | IP chemo-AGC |
| Study First Received: | October 8, 2009 |
| Last Updated: | September 7, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Fudan University:
|
intraperitoneal chemotherapy cisplatin fluorouracil advanced gastric cancer |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Adjuvants, Immunologic Cisplatin Fluorouracil |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013