Phase 2 Pancreatic 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:

• Adults aged 18 or older who have a well or moderately differentiated neuroendocrine tumour (NET) of the mid-gut, hind-gut, or pancreas that has spread to other parts of the body and cannot be removed by surgery, and whose tumour has continued to grow despite receiving a somatostatin analogue (SSA) medication.
• People whose tumour can be measured on a specialised CT or MRI scan, following a standard measurement method called RECIST 1.1.
• People whose tumour has a low growth rate, specifically a Ki67 score of 20% or below and a mitotic count of 20 or fewer per high-powered field (WHO grade 1 or 2) (confirm with trial site).
• People who have been receiving SSA medication at a specific minimum dose — at least 30mg of Octreotide or 120mg of Lanreotide monthly — for at least 12 weeks before entering the study.
• People whose tumour shows up on a specific type of scan (SSTR PET scan) in a way that the clinical team considers suitable for a type of treatment called PRRT (a form of targeted radiation therapy).
• People for whom PRRT has been determined by their medical team to be the most appropriate next treatment step — meaning surgery is not possible and other liver-targeted treatments are not preferred.
• People with a performance status score of 0, 1, or 2 on the ECOG scale, meaning they are able to carry out daily activities to a reasonable degree (confirm with trial site).
• People who are willing to give written consent to participate and to either stop or continue SSA medication depending on which group they are assigned to, and who are willing to follow all other study requirements.
• People whose kidney, liver, and blood functions are considered adequate by their treating medical team.
• People with a life expectancy of at least 12 months.
• People with a non-functioning NET — meaning their SSA treatment was started to slow tumour growth, not to manage hormone-related symptoms such as those caused by carcinoid syndrome — as determined by the treating team. Additional specific criteria apply to confirm the tumour is non-functioning (confirm with trial site).
• Having tumour tissue samples available from a previous surgery or biopsy is preferred but is not required to join the study. Research samples, including blood samples, will only be collected from people who separately agree to optional research participation.

Who may not be able to join:

• People whose NET originated in the stomach or lungs — this trial is for pancreatic, mid-gut, and hind-gut NETs only.
• People who have been receiving SSA medication at a lower dose than the standard growth-control dose (below 30mg Octreotide or 120mg Lanreotide monthly, or for less than 3 months).
• People who have previously received chemotherapy or targeted therapy drugs such as everolimus. (Note: prior local treatments such as external beam radiotherapy or liver-directed therapy are generally not disqualifying — confirm with trial site.)
• People who have any reason they cannot safely receive PRRT, according to their treating institution's guidelines.
• People who are pregnant. People of childbearing potential, or male patients whose female partners are of childbearing potential, will need to use contraception and receive counselling.
• People who have previously received PRRT, including those being considered for re-treatment.
• People who have uncontrolled cancer that has spread to the brain or central nervous system. If prior surgery or radiation for this has occurred, it must have been completed at least 4 weeks before registering, and steroid medications must have been stopped for at least 2 weeks.
• People who, in the opinion of the investigator, are unlikely to be able to attend study appointments and follow-up visits, which may include concerns related to social, psychological, or geographical factors, or alcohol or drug use.
• People with poorly controlled ongoing medical conditions that may prevent them from completing study assessments, as judged by their treating team.
• People with another current or past cancer that, in the opinion of the treating team, may interfere with study results or measurements.

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