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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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26 February 2018 |
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Main ID: |
ISRCTN13223892 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised trial comparing the efficacy of intraperitoneal (IP) drainage with or without intraperitoneal cisplatin for malignant ascites in gastrointestinal cancer
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Scientific title:
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A randomised trial comparing the efficacy of intraperitoneal (IP) drainage with or without intraperitoneal cisplatin for malignant ascites in gastrointestinal cancer |
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Date of first enrolment:
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05/07/1994 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN13223892 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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David
Cunningham |
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Address:
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Department of Medicine
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
Surrey
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically verified locally advanced or metastatic adenocarcinoma of the gastrointestinal tract
2. Clinically confirmed symptomatic ascites
3. Glomerular filtrate rate of >40ml/min
4. Patients must not have received intraperitoneal cisplatin before
5. No concurrent intravenous cisplatin, and at least a 2 week gap after the completion of intravenous cisplatin before intraperitoneal therapy can be commenced
6. Intravenous chemotherapy (except cisplatin) may be given concurrently
7. No medical contraindications to treatment
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Oesophagus/stomach cancer
Cancer
Malignant neoplasm of other and ill-defined digestive organs
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Intervention(s)
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Two arms:
1. IP drainage alone
2. IP drainage and IP cisplatin
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Primary Outcome(s)
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1. Toxicity
2. Ascites free survival
3. Time to ascites re-accumulation
4. Overall survival
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Secondary Outcome(s)
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No secondary outcome measures
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Secondary ID(s)
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RMH E/C 1009
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Source(s) of Monetary Support
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Royal Marsden Hospital (UK)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2002 |
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URL:
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