MRC Adjuvant Gastric Infusional Chemotherapy Trial
| ISRCTN | ISRCTN93793971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93793971 |
| Protocol serial number | ST02 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Two armed, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | MRC Adjuvant Gastric Infusional Chemotherapy Trial |
| Study acronym | MAGIC |
| Study objectives | To investigate whether peri-operative chemotherapy prolongs survival |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Chemotherapy |
| Primary outcome measure(s) |
1. Survival time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/06/1994 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
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? |
|---|---|---|---|---|---|
| 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.
