Phase 2 Oesophageal Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with a specific type of cancer (adenocarcinoma) of the oesophagus (food pipe) or the junction between the oesophagus and stomach, at a stage where the cancer has spread to nearby lymph nodes but not to distant parts of the body, and where surgery to remove the cancer is considered possible by the medical team.
• People whose cancer has been assessed using specific scans (PET/CT scan and/or endoscopic ultrasound) to confirm the stage of the disease.
• People whose tumour grows no more than 4 cm into the upper part of the stomach (cardia), as measured by a camera examination of the food pipe.
• People where the cancer or affected lymph nodes meet specific location requirements in relation to the diaphragm (the muscle separating the chest and abdomen) (confirm with trial site).
• People aged 18 or older. Those aged 70 or older will need to complete an additional health and functioning assessment before joining.
• People who have not previously had radiotherapy in the chest, abdomen, or neck that would overlap with the treatment area used in this trial.
• People who have not previously received chemotherapy for oesophageal cancer.
• People who are in good general health, able to carry out normal daily activities, or limited only in strenuous physical activity (as measured by a standard medical scoring tool called ECOG Performance Status 0–1).
• People who have lost less than 10% of their body weight.
• People with adequate heart and lung function.
• People with adequate blood cell counts — specifically, white blood cells, haemoglobin (red blood cell protein), and platelets must all be above certain minimum levels. If a blood transfusion has been given, it must have been more than two weeks before joining the trial.
• People with adequate kidney and liver function, confirmed by blood tests.
• Women who could become pregnant must have a negative pregnancy blood test before joining the trial.
• People who are willing and able to use effective contraception during the trial and for up to 3 months after it ends.
• People who are able to understand what the trial involves and are willing to give written consent to participate.

Who may not be able to join:

• People whose oesophageal or stomach junction cancer is not the adenocarcinoma type (for example, squamous cell or adenosquamous cancers).
• People who are eligible for and wish to participate in a separate clinical trial called TRAP-2 (NCT05188313).
• People whose cancer has spread to other organs, distant lymph nodes (such as in the neck or behind the abdomen), or the lining of the abdomen or chest cavity, as detected by scans. People who have a camera examination of the abdomen (laparoscopy) that shows cancer cells in the abdominal fluid are also not eligible.
• People with significant active heart disease (for example, chest pain from heart disease or a heart attack within the past 12 months) or significant lung disease (with lung capacity below a certain level on breathing tests).
• People with nerve damage in the hands or feet (peripheral neuropathy) that is more than mild in severity.
• People who carry two copies of a specific gene variation (DPYD) that affects how certain chemotherapy drugs are processed by the body (confirm with trial site).
• Women who are pregnant or breastfeeding, or people of reproductive age who are not using effective contraception.
• People who have another active cancer that could affect their overall outlook or prognosis.
• People who are unlikely to be able to follow the trial's requirements as set out by the medical team.
• People who, due to language barriers, dementia, or other cognitive difficulties, are unable to understand the study, give informed consent, or complete quality-of-life questionnaires. People who do not speak the main language of the study site may still be considered if information can be adequately translated or explained to them and they can show they understand what is involved.

Important: Always verify eligibility with the trial site directly before applying.