Phase 3 Oesophageal Cancer Trial, Recruiting

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

Who might be able to join this trial:

• You have been diagnosed with a type of cancer called adenocarcinoma in the esophagus (food pipe) or at the point where the esophagus meets the stomach, confirmed by a tissue sample (biopsy), and it is at a specific stage that has not spread to distant parts of the body.
• Your tumor tests positive for a protein called HER2, confirmed by specific laboratory tests on your tumor tissue.
• Doctors have determined, through a team discussion, that your tumor can be surgically removed.
• If your tumor extends into the upper part of the stomach, the main bulk of it must still be in the esophagus or the junction area.
• You are 18 years of age or older.
• You are generally well enough to carry out daily activities with little to no restriction (as assessed by your doctor using a standard scale).
• Your blood counts, kidney function, and liver function are within acceptable levels as measured by blood tests.
• Your heart is pumping well enough, confirmed by a heart scan (at least 55% pumping efficiency).
• You are willing and able to give written consent to take part in the trial.
• You are able to attend follow-up appointments and receive treatment at the trial centre.

Who may not be able to join:

• Your cancer is at a very early stage with no spread to lymph nodes, or it is a non-invasive (in situ) cancer.
• You have had, or currently have, another cancer within the past 5 years that is expected to have a worse outlook than your current esophageal cancer.
• You have previously received chemotherapy, radiotherapy, or treatments targeting HER2 for esophageal or any other cancer within 6 months of your esophageal cancer diagnosis.
• You have had previous radiation treatment to the chest area (mediastinum) that would prevent you from receiving the full dose of radiation needed for your current tumor.
• Your cancer has grown into the airway (windpipe and branches) or there is an abnormal opening between the esophagus and the airway (tracheoesophageal fistula).
• You are pregnant, planning to become pregnant, or are currently breastfeeding.
• You are not willing to use reliable contraception during treatment and for 6 months after treatment ends (this applies to both men and women).
• You have significant heart problems, such as a recent heart attack, unstable chest pain, heart failure, or serious uncontrolled irregular heartbeat, that would make major surgery too risky.
• You have severe lung scarring or very poor lung function that would make major surgery too risky.
• You have a serious underlying health condition that would prevent you from receiving the planned treatment, including a history of severe allergic reactions to certain medications (such as those containing an ingredient called Cremophor).
• You have dementia or a condition that affects your thinking in a way that would prevent you from understanding and giving informed consent.
• You are unable to eat or drink enough to meet your nutritional needs, even with the help of a dietitian or tube feeding.
• You have a lung condition involving inflammation or scarring of lung tissue (interstitial lung disease or active pneumonitis).
• You have an active infection that requires medication and has not cleared up within 3 to 7 days before starting the trial treatment.
• You have a current or past infection with Hepatitis B, Hepatitis C, or HIV.
• You have previously had a transplant of bone marrow stem cells or a solid organ (such as a kidney or liver).
• You already have existing nerve damage affecting movement or sensation at a moderate or severe level (confirm with trial site).

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