None listed
Conditions
Brief summary
People with cancer of the oesophagus (gullet) often have trouble swallowing. Radiotherapy can help improve this problem. Using chemotherapy together with radiotherapy may work better but has more side effects. This trial will determine if it is better to use radiotherapy by itself or together with chemotherapy.
Interventions
Arm 2: Chemo-radiotherapy. 35Gy in 15 fractions (Overall, treatment time will not exceed 25 days total for the 3 week course and 18 days for the 2 week course of radiation) plus Cisplatin 80mg/m squared IV day 1 (or 20mg/m sqaured/day IV each day from 1-4 only one cycle) plus 5-Fluorouacil 800mg/m squared/day IV days 1-4 (radiotherapy and chemotherapy are simultaneous)
Sponsors
Trans Tasman Radiation Oncology Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 (it should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment). 3. Symptomatic patients with dysphagia scores of => 1 i.e. able to eat only some sollids (see appendix 1) 4. Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2 5. Patients msut begin treatment within 2 weeks of randomisation 6. Patient is at least 18 years old 7. Adequate haematology function to undergo chemotherapy Peripheral blood - Neutrophils > 1.5 x 109/L - Platelets > 100 x 109/L 8. Adequate renal function, Creatine - Calculated clearence 50 ml/min (see appendix 1). 9. Patients capable of child bearing are using adequate contraception. 10. Written informed consent of patient.
Exclusion criteria
1. Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest. 2. Synchronous active malignancies. 3. Pregnant or lactating patients. 4. Patients unfit for any treatment component. 5. Tracheo-oesophageal fistula. 6. Stents in situ. 7. Previous chemotherapy for Oesophageal Cancer 8. CT scan of thorax and abdomen more than 8 weeks prior to randomisation 9. Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomisation
Outcome results
None listed