ISRCTN ISRCTN81192724
DOI https://doi.org/10.1186/ISRCTN81192724
Protocol serial number RMH E/C 1109
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
08/11/2022
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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA Randomised trial of Adjuvant Chemotherapy in Oesophago-Gastric Cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOesophagus, Stomach
Intervention1. ECF - 5FU 200 mg/m2 continuous infusion Epirubicin 50 mg/m2 3-weekly IV bolus Cisplatin 60 mg/m2 3 weekly
2. Best supportive care (no treatment)
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Chemotherapy drugs
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteria1. Histological squamous or adenocarcinoma of oesophagus or adenocarcinoma of stomach
2. Disease completely resected - no evidence of metastases after staging investigations
3. Surgery within the past 16 weeks
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications interim analysis 01/05/1998 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

08/11/2022: Proactive update review. No publications found. Search options exhausted.