Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/C 1009
Study information
Scientific title
A randomised trial comparing the efficacy of intraperitoneal (IP) drainage with or without intraperitoneal cisplatin for malignant ascites in gastrointestinal cancer
Acronym
IPCISPLATIN
Study hypothesis
To determine the ascites-free survival of intraperitoneal (IP) drainage with IP cisplatin for malignant ascites in gastrointestinal (GI) cancer.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oesophagus/stomach cancer
Intervention
Two arms:
1. IP drainage alone
2. IP drainage and IP cisplatin
Intervention type
Drug
Phase
Not Specified
Drug names
Cisplatin
Primary outcome measure
1. Toxicity
2. Ascites free survival
3. Time to ascites re-accumulation
4. Overall survival
Secondary outcome measures
No secondary outcome measures
Overall trial start date
05/07/1994
Overall trial end date
31/08/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
17
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
05/07/1994
Recruitment end date
01/11/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine
Surrey
SM2 5PT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list