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:

• People who have been diagnosed with a confirmed cancer of the food pipe (esophagus) or the junction between the food pipe and the stomach, of a specific cell type (squamous cell carcinoma, adenocarcinoma, signet cell carcinoma, or large cell carcinoma).
• People who have had a specific type of scan called an FDG PET/CT scan performed.
• People whose cancer has been staged as locally present in the food pipe wall and/or spread to nearby lymph nodes, but not to distant parts of the body (stage cT1–4a and/or cN+, cM0 according to the TNM 8th edition staging system).
• People aged 18 years or older.
• People with a general health and activity level rated as WHO performance status 2 or better (meaning able to care for themselves and active for at least half of waking hours).
• People whose blood test results meet minimum levels for red blood cells, white blood cells, platelets, liver function, and kidney function (confirm with trial site for exact values).
• People whose case has been reviewed by a multidisciplinary medical team, who have decided that treatment with chemotherapy combined with either radiation or proton therapy before surgery is appropriate with the goal of curing the disease.
• People who are planned to have a specific type of surgery to remove part or all of the food pipe or stomach (transthoracic esophagectomy or gastrectomy, performed open, minimally invasive, or a combination).
• People who are able and willing to follow the study procedures and attend follow-up appointments.
• People who have a previous low-risk cancer (such as low-risk prostate cancer) with a life expectancy above 5 years may still be eligible.
• People who have had certain fully treated, non-invasive cancers (such as cervical carcinoma in situ, non-invasive bladder cancer, or localised non-melanoma skin cancer) may still be eligible regardless of when those were diagnosed.
• People who could become pregnant must have a negative pregnancy test before joining and must use an approved form of contraception throughout treatment and for one month after.

Who may not be able to join:

• People who have previously received radiation therapy or proton therapy to the chest, chemotherapy, or surgery to remove part of the food pipe or stomach (note: certain minor endoscopic procedures such as EMR or ESD are allowed).
• People whose tumour is located less than 3 cm from the upper throat sphincter.
• People who are planned to have a type of surgery called transhiatal resection.
• People who have had another cancer in the past, unless it was completely cleared or removed at least 5 years before entering the study (certain exceptions apply — confirm with trial site).
• People with serious or unstable ongoing health conditions, including significant lung disease, heart disease, unstable angina, severe heart failure (NYHA grade III–IV), or severe liver, kidney, or metabolic disease, or active inflammatory bowel disease.
• People who have nerve damage in the hands or feet causing symptoms beyond a mild level (greater than grade 1 peripheral neuropathy according to standard medical grading).
• People with any other serious or uncontrolled illness that the trial doctor considers would make participation inadvisable.
• People who are unable to understand the trial information or follow the treatment and safety instructions.
• People who have a stent (a small tube used to keep the food pipe open) placed within the area that would be treated with radiation.

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