Advanced, oesophageal, oesophago-gastric junctional and gastric cancers. Cancer Gastrointestinal
Conditions
Interventions
Treatment should commence within 28 days of baseline CT scan and may continue for up to 24 weeks with a maximum of 8 cycles of epirubicin, cisplatin or oxaliplatin.
Patients are randomised to receiv
Sponsors
The Royal Marsden NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically verified locally advanced or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction, or stomach. Patients with positive resection margin or tumour within 1mm of resection margin are eligible. 2. Uni-dimensionally measurable disease, as assessed by computed tomography (CT) and magnetic resonance imaging (MRI) scan in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines; evaluable disease, for example on oesophagogastroscopy. The only exception is patients with positive or close resection margins who will be evaluated for survival only. 3. No prior chemotherapy 4. No prior radiotherapy other than adjuvant where relapse is outside the radiotherapy fields 5. A glomerular filtration rate (GFR) of =60 ml/min by EDTA clearance or 24 hour urinary creatinine, investigator?s discretion. Normal serum creatinine. 6. Serum bilirubin 3 x 10^9/l, neutrophils >1.5 x 10^9/l, platelets >100 x 10^9/l 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Medical or psychiatric condition impairing the ability to give informed consent 2. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or clinically significant abnormal electrocardiogram (ECG) or cardiac history having a left ventricular ejection fraction (LVEF) of lower limit of normal range for institution as determined by multiple gated acquisition (MUGA) scan or echocardiogram 3. Any other serious uncontrolled medical conditions 4. Any pregnant or lactating woman. Any woman of child bearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment. Any man with a partner of child bearing potential must take adequate precautions to prevent pregnancy during treatment. 5. Inability to complete the quality of life questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is overall survival. The study is powered to demonstrate non-inferiority of the 2 x 2 comparisons. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response Rates 2.Toxicity 3. Duration of response and progression free survival 4. Quality of life 5. In the phase I part of the study, to establish the optimal dose of capecitabine in the regimens | — |
Countries
United Kingdom
Outcome results
None listed