A randomised trial comparing the efficacy of intraperitoneal (IP) drainage with or without intraperitoneal cisplatin for malignant ascites in gastrointestinal cancer

ISRCTN	ISRCTN13223892
DOI	https://doi.org/10.1186/ISRCTN13223892
Secondary identifying numbers	RMH E/C 1009

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 14/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Cunningham
Scientific

Department of Medicine
Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised trial comparing the efficacy of intraperitoneal (IP) drainage with or without intraperitoneal cisplatin for malignant ascites in gastrointestinal cancer
Study acronym	IPCISPLATIN
Study objectives	To determine the ascites-free survival of intraperitoneal (IP) drainage with IP cisplatin for malignant ascites in gastrointestinal (GI) cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oesophagus/stomach cancer
Intervention	Two arms: 1. IP drainage alone 2. IP drainage and IP cisplatin
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	05/07/1994
Completion date	31/08/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	17
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	05/07/1994
Date of final enrolment	01/11/1996

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Medicine

Surrey
SM2 5PT
United Kingdom

Sponsor information

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

"ROR"	https://ror.org/0008wzh48

Funders

Funder type

Hospital/treatment centre

Royal Marsden Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

14/02/2018: No publications found in PubMed, verifying study status with principal investigator.
23/12/2015: This study was closed to recruitment on the 15th March 2001 due to slower than anticipated recruitment.
30/11/2015: No publications found in PubMed.