Advanced Gastric CancerPhase 2IPchemo-AGCNCT00992199
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
A Phase 2 study testing cisplatin, Fluorouracil in people with Advanced Gastric Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- cisplatin, Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 29Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Jin Li, MD, 86(021)64175590 ext. 5108, fudanlijin@163.com
Xiaodong Zhu, MD, 86(021)64175590 ext. 5008, xddr001@163.com
About this study
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.
Read the detailed description
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.
- Conditions
- Advanced Gastric Cancer
- Being tested
- cisplatin, Fluorouracil
- Keywords
- intraperitoneal chemotherapy, cisplatin, fluorouracil, advanced gastric cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin, FluorouracilDrug
Also called DDP,5-Fu
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
| Study group | Role | What they receive |
|---|---|---|
| control arm | No intervention | adjuvant intravenous system chemotherapy |
| IP Chemo arm | Experimental | adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy Receives: Drug: cisplatin, Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis in Peritoneum and peritoneal cavity
Measured: 1 year
Secondary outcomes (3)
Liver metastasis
Measured: 1 year
Refraction-free survival
Measured: 1 year
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jin Li, MD, Principal investigator, member of Fudan University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992199
- Sponsor's protocol ID
- IP chemo-AGC
- Acronym
- IPchemo-AGC
- Status last verified
- Sep 2010
- First submitted
- 8 Oct 2009
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00992199
- Acronym / sponsor ID
- IPchemo-AGC / IP chemo-AGC
- Conditions
- Advanced Gastric Cancer
- Keywords
- intraperitoneal chemotherapy, cisplatin, fluorouracil, advanced gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | –adjuvant intravenous system chemotherapy |
| IP Chemo arm | Experimental | Drug: cisplatin, Fluorouraciladjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
- Age: 18 - 70years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin, FluorouracilAlso: DDP,5-Fucisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times | Drug | IP Chemo arm |
Primary outcome
Metastasis in Peritoneum and peritoneal cavity
Time frame: 1 year
3 secondary outcomes
Liver metastasis
Time frame: 1 year
Refraction-free survival
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Li, MD principal investigator
member of Fudan University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, Fluorouracil in people with Advanced Gastric Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Li, MD (86(021)64175590 ext. 5108, fudanlijin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis in Peritoneum and peritoneal cavity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.