Oesophageal or gastric cancer Cancer
Conditions
Interventions
Participants will be randomized by the local study team via a centralised validated computer randomisation program through a secure (encrypted) web-based service, RRAMP (https://rramp.octru.ox.ac.uk),
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: A patient will be eligible for inclusion in this study if all of the following criteria apply: 1. Has undergone surgical resection for curatively intended treatment of oesophageal or gastric cancer (adenocarcinoma and squamous cell carcinoma) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy or immunotherapy (or in combination). 2. Aged 16 years or over 3. Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: A patient with not be eligible for the trial if ANY of the following apply: 1. Has other cancers undergoing treatment or surveillance for this cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality, defined as death from any cause. Participants who have not been observed to die during the course of the study will have their survival time censored at their last known follow-up date (evaluated at 3 years post-randomisation of the last included participant) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-specific mortality, defined as known oesophageal or gastric cancer recurrence at the time of death, evaluated using the participant’s medical notes at 3 years post-randomisation of the last included participant 2. Pattern of tumour recurrence, defined as the incidence of loco-regional or distant recurrence, evaluated using the participant’s medical notes including CT reports at 3 years post-randomisation of the last included participant 3. Treatment of tumour recurrence, i.e. the requirement for chemotherapy, surgery, immunotherapy, radiotherapy, chemoradiotherapy, best supportive care or other as determined by the clinical team at the treating site, evaluated using the participant’s medical notes at 3 years post-randomisation of the last included participant 4. Rates of oligometastatic (one site) tumour recurrence evaluated using the participant’s medical notes including CT reports at 3 years post-randomisation of the last included participant 5. Rates of multi-metastatic (several sites) tumour recurrence evaluated using the participant’s medical notes including CT reports at 3 years post-randomisation of the last included participant 6. Health-related quality of life, including anxiety or depression and worry of cancer returning, measured by the following validated questionnaires: 6.1. EQ-5D-5L 6.2. EORTC QLQ-C30 6.3. EORTC QLQ-OG25 6.4. Cancer Worry Scale Participant-reported outcome (questionnaires administered and data collected centrally) at baseline, 6, 12, 18, 24, 30 and 36 months post-randomisation. 7. Incremental cost per quality-adjusted life year (QALY): participant-reported outcome (questionnaires administered and data collected centrally) and participant’s medical records for resources used in secondary care collected at baseline 6, 12, 18, 24, 30 and 36 months post-randomisation. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed