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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial comparing the efficacy of intraperitoneal (IP) drainage with or without intraperitoneal cisplatin for malignant ascites in gastrointestinal cancer
Study acronymIPCISPLATIN
Study objectivesTo 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) studiedOesophagus/stomach cancer
InterventionTwo arms:
1. IP drainage alone
2. IP drainage and IP cisplatin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cisplatin
Primary outcome measure1. Toxicity
2. Ascites free survival
3. Time to ascites re-accumulation
4. Overall survival
Secondary outcome measuresNo secondary outcome measures
Overall study start date05/07/1994
Completion date31/08/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants17
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment05/07/1994
Date of final enrolment01/11/1996

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.