Advanced oesophago-gastric cancer Cancer Malignant neoplasm of stomach
Conditions
Interventions
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 we
Sponsors
The Royal Marsden NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed