A Randomised trial of Adjuvant Chemotherapy in Oesophago-Gastric Cancer
| 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A Randomised trial of Adjuvant Chemotherapy in Oesophago-Gastric Cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oesophagus, Stomach |
| Intervention | 1. 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 type | Drug |
| Phase | Not 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 date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. 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 criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
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 | Not 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 |
Editorial Notes
08/11/2022: Proactive update review. No publications found. Search options exhausted.
