Incurable gastric or oesophageal carcinoma in frail or elderly patients Cancer Malignant neoplasm of oesophagus
Conditions
Interventions
Starting doses:
Arm 1: EOX (control) - Epirubicin (40 mg/m2), oxaliplatin (104 mg/m2), X capecitabine (500mg/m2 twice a day [bd] for 21 days)
Arm 2: OX - Oxaliplatin (1
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females 2. Histologically confirmed carcinoma of the oesophagus, GO-junction or stomach, of either squamous, adenocarcinoma or undifferentiated type 3. With or without distant metastases, but if M0, must be planned for treatment with palliative intent 4. No previous chemotherapy for GO cancer 5. Considered by treating consultant to be fit/suitable for reduced-dose chemotherapy (normally WHO PS =30 ml/min 7. Hepatic function: Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) <=2.5 x upper limit of normal (ULN) and bili <= 1.5 x ULN 8. Projected life expectancy of at least 3 months 9. Unidimentionally measurable disease on computerised tomography (CT) or magnetic resonance imaging (MRI) scan with the response evaluation criteria in solid tumours (RECIST)
Exclusion criteria
Exclusion criteria: 1. Fit, suitable and willing for standard full-dose combination chemotherapy with EOX (epirubicin, oxaliplatin, X capecitabine) or equivalent 2. Medical or psychiatric condition impairing ability to consent or comply with assessments including Quality of life questionnaire 3. Requiring ongoing treatment with a contraindicated medication 4. Age <18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The rate of patient randomisation into 321GO over the 18 month recruitment period in the 2 participating cancer networks 2. The number of patients at each participating network considered for palliative chemotherapy for advanced GO cancer, and the proportion randomised into 321GO | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The tolerability of each regimen, assessed in terms of the following: 1.1. The incidence of CTCAEv3 grade >= 3 non-haematological toxicities at 6 weeks 1.2. The incidence of SAEs and dose delays/reductions 1.3. The ability/willingness to dose-escalate to 100% at week 6 2. Patient acceptability scores at 12 and 24 weeks 3. Quality of life, nutritional and symptom changes at 0, 12 and 24 weeks: 3.1. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) with Gastroesophageal module 3.2. 24-point Nottingham Instrumental Activities of Daily Living (IADL) tool 3.3. Mini-nutritional assessment questionnaire 3.4. Mini-Mental State Examination 3.5. Charlson co-morbidity score 3.6. Euroqol (EQ-5D) questionnaire 4. Progression-free survival for the whole group (combining all 3 treatment arms) | — |
Countries
England, United Kingdom
Outcome results
None listed