A randomised study of continuous infusional 5-fluorouracil (5FU) with or without bolus mitomycin-C in patients with advanced oesophago-gastric cancer
Completed
- Conditions
- Advanced oesophago-gastric cancerCancerMalignant neoplasm of stomach
- Registration Number
- ISRCTN43866427
- Lead Sponsor
- The Royal Marsden NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 254
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Added 16/04/2009:<br>1. Tumour response, assessed by computed tomography (CT) scan before chemotherapy, 6-weekly during chemotherapy and 3-monthly thereafter until death or disease progression<br>2. Survival<br>3. Toxicity, evaluated on a weekly basis and graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC)<br>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
Name Time Method o secondary outcome measures