MRC Adjuvant Gastric Infusional Chemotherapy Trial
| ISRCTN | ISRCTN93793971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93793971 |
| Secondary identifying numbers | ST02 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 28/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms Monica Verma
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| not@provided.com |
Study information
| Study design | Two armed, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | MRC Adjuvant Gastric Infusional Chemotherapy Trial |
| Study acronym | MAGIC |
| Study hypothesis | To investigate whether peri-operative chemotherapy prolongs survival |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Gastrointestinal cancer |
| Intervention | Three cycles of pre- and post-operative ECF (Epirubicin, Cisplatin and 5-Fluorouracil) chemotherapy versus surgery alone. Follow-up: all patients will be followed 6 monthly to 2 years then annually until death. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Chemotherapy |
| Primary outcome measure | 1. Survival time 2. Disease-free survival 3. Quality of life 4. Tumour response |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 20/06/1994 |
| Overall study end date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 500 |
| Participant inclusion criteria | 1. Histologically proven adenocarcinoma (Stage II or greater) of the lower third oesophagus or stomach, that is considered to be non-urgently resectable with no evidence of distant metastasis 2. Suitable and fit for cytotoxic chemotherapy 3. WHO performance status of 0 or 1 |
| Participant exclusion criteria | 1. Other malignant disease other than non-melanomatous skin cancer or in situ carcinoma of the cervix; 2. previous cytotoxic chemotherapy or radiotherapy |
| Recruitment start date | 20/06/1994 |
| Recruitment end date | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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? |
|---|---|---|---|---|---|
| Results article | Results | 06/07/2006 | Yes | No | |
| Plain English results | 28/10/2021 | No | Yes |
Editorial Notes
28/10/2021: Cancer Research UK plain English results link added.
