Topic: National Cancer Research Network
Conditions
Interventions
GO2 has no fixed sample size. The trial aims to recruit a minimum of 500 participants to the chemotherapy arms, and an additional 30 participants to the BSC arm over 3 years. However, should accrual
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed carcinoma of the oesophagus, GO junction or stomach 2. With or without distant metastases, but if M0, being treated with palliative intent 3. Considered by the treating physician to be fit/suitable for any of the GO2 regimens. 4. Renal function: estimated or measured GFR >=30 ml/min (if in the range 3050ml/min, reduced doses of both drugs must be used) 5. Hepatic function: bilirubin =1.5 x10^9/l; white blood cell count >=3 x10^9/l; platelets >=100 x10^9/l. 7. Written informed consent 8. Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Fit, suitable (as judged by the treating clinician) and willing for standard full dose combination chemotherapy with EOX or equivalent 2. Previous palliative chemotherapy for GO cancer 3. Medical or psychiatric condition impairing ability to consent or comply with oral chemotherapy or trial assessments (including patient reported outcome measures) 4. Other malignancy if, in the opinion of the treating physician, this would significantly impede interpretation of the outcome of the trial treatment 5. Age <18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy intensity comparison: 1. Progression free survival Chemotherapy vs best supportive care comparison 1. Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemotherapy intensity comparison: 1. Participant reported fatigue 2. Time to deterioration of participant reported fatigue 3. Overall treatment utility 4. Quality of life and symptoms 5. Toxicity 6. Overall survival 7. Quality adjusted survival 8. Best response Chemotherapy vs best supportive care comparison: 1. Participant reported fatigue 2. Quality of life Comprehensive Health Assessment (CHA) ? pre-randomisation EQ-VAS ? weekly until week 18 Short follow-up questionnaire ? 3-weekly until week 18, then weeks 27, 36 and 52 Limited Health Assessment ? week 9 | — |
Countries
England, United Kingdom
Outcome results
None listed