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

Not Applicable

Completed

• Conditions: Malignant neoplasm of other and ill-defined digestive organs; Oesophagus/stomach cancer; Cancer

• Registration Number: ISRCTN13223892
• Lead Sponsor: The Royal Marsden NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-08-19
• Study Completion: 2002-08-31
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 17

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

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Toxicity<br>2. Ascites free survival<br>3. Time to ascites re-accumulation<br>4. Overall survival

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures