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 |
| Protocol serial number | RMH E/C 1009 |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital (UK) |
- 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
Scientific
Department of Medicine
Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cisplatin |
| Primary outcome measure(s) |
1. Toxicity |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/08/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Medicine
Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
