Advanced oesophageal cancer
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Intravenous infusion
Product Name: 5 Fluorouracil
Pharmaceutical Form:
Sponsors
Hull & East Yorkshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biopsy proven carcinoma of the oesophagus 2. Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. 3. Symptomatic patients with dysphagia scores of >=1 ie able to eat only some solids 4. Performance status ECOG >=2 5. Patients must begin treatment within 2 weeks of randomisation 6. Patient must be at least 18 years old 7. Adequate haematological function to undergo chemotherapy. Peripheral blood - neutrophils >1.5 x 109/L - Platelets >100 x 109/L 8. Adequate haematological function, creatinine clearance >- 60 ml/min 9. Patients capable of childbearing are using adequate contraception 10. Written informed consent of patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. No previous external beam Radiotherapy or brachy-therapy delivered to the region of the chest 2. Synchronous active malignancies 3. Pregnant of lactating patients 4. Patients unfit for any treatment component 5. Tracheo-oesophageal fistula 6. Stents insitu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.; Secondary Objective: 1. Dysphagia progression-free survival 2. Time to achieving any response in dysphagia after treatment 3. Number of patients receiving secondary treatment (radiation, chemotherapy or stenting) 4. Quality of life differences post-treatment and at three and six months 5. Acute and late toxicity 6. Survival ;Primary end point(s): The primary study end point is relief of dysphagia, defined as improvement of at least one point on the Mellow scale. This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter. Radiation treatment must start within 2 weeks of randomisation. | — |
Countries
United Kingdom
Outcome results
None listed