A randomised study of continuous infusional 5-fluorouracil (5FU) with or without bolus mitomycin-C in patients with advanced oesophago-gastric cancer
| ISRCTN | ISRCTN43866427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43866427 |
| Secondary identifying numbers | RMH E/C 1040 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 21/11/2012
- 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
Dr D Cunningham
Scientific
Scientific
GI and Lymphoma Units
Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Added 16/04/2009: To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin C (MMC) in patients with advanced oesophago-gastric cancer. As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date. |
| Ethics approval(s) | Added 16/04/2009: The study was approved by the Local Research and Ethics Committee at each of the five participating centres. |
| Health condition(s) or problem(s) studied | Advanced oesophago-gastric cancer |
| Intervention | Two arms: 1. Protracted venous infusion (PVI) 5FU 300 mg/m^2/day over 24 weeks 2. PVI 5FU 300 mg/m^2/day over 24 weeks and mitomycin-C 7 mg/m^2 (total dose no more than 56 mg) four courses over 24 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil (5FU), mitomycin-C |
| Primary outcome measure | Added 16/04/2009: 1. Tumour response, assessed by computed tomography (CT) scan before chemotherapy, 6-weekly during chemotherapy and 3-monthly thereafter until death or disease progression 2. Survival 3. Toxicity, evaluated on a weekly basis and graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) 4. Quality of life, assessed using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires before randomisation and every 12 weeks thereafter |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/07/1994 |
| Completion date | 31/03/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 254 |
| Key inclusion criteria | 1. Histological evidence of metastatic carcinoma of the oesophagus or stomach 2. Histological evidence of locally advanced oesophageal or gastric carcinoma, not amenable to surgery or radiotherapy and for whom high dose chemotherapy or more intensive chemotherapy is not appropriate, normally around the age of 60 |
| Key exclusion criteria | 1. Intra-cerebral metastases 2. History of other malignancy (apart from adequately treated non-melanotic skin cancer or carcinoma in situ of the uterine cervix) 3. Uncontrolled angina pectoris or clinically significant cardiac dysrhythmias 4. Pregnancy 5. Any psychological condition precluding informed consent |
| Date of first enrolment | 01/07/1994 |
| Date of final enrolment | 31/03/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GI and Lymphoma Units
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
SM2 5PT
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Hospital/treatment centre
The Royal Marsden NHS Foundation Trust (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2002 | Yes | No |
