Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
23/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Cunningham

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.