ABC-07

 Fibrillary astrocytoma / Posted 1 year ago

ABC-07: A trial looking at stereotactic body radiotherapy and chemotherapy for people with locally advanced bile duct cancer

The purpose of the ABC-07 trial is examine whether adding radiotherapy called Stereotactic Body Radiotherapy (SBRT) to chemotherapy will improve the outcome for patients with locally advanced biliary tract cancer that are unfit for surgery. All patients will receive 6 cycles of chemotherapy and then they will receive either 5 fractions of SBRT or 2 more cycles of chemotherapy depending on which treatment they are randomised to.
Initially we plan to undertake a feasibility phase to see if it is possible to recruit patients into the trial and then we will continue with the randomised phase II study. Patients recruited during this feasibility stage will be included in the analysis of the full randomised phase II study.

  • Inclusion Criteria : You have cancer of the bile duct that has spread into surrounding tissues and can’t be removed with an operation Your cancer can be seen on a scan Your tumour doesn't measure more than 12cm across - if it isn't possible to measure because of where it is in the body, you might be able to take part if it is visible for radiotherapy with another type of test such as an ERCP You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1) You have satisfactory blood test results You are willing to use at least 1 form of reliable contraception during the trial and for at least 6 months after the last dose of chemotherapy if there is any chance you or your partner could become pregnant. If you have SBRT, you should continue to use the contraception for at least 12 months after you finish treatment You are at least 16 years old
  • Exclusion Criteria : You have cancer of the gallbladder You have cancer that has spread to another part the body Your cancer has grown into your stomach or part of your digestive system called the small and large bowel You have had radiotherapy to your tummy (abdomen) or a type of internal radiotherapy called SIRT such as Yttrium treatment into the main artery near the liver (hepatic artery) You have had a reaction to substances called platinum salts in the past You are having any other type of cancer treatment apart from steroids You have had another cancer in the last 2 years apart from successfully treated early cancers or any other cancer that has been treated with the aim to cure You have any severe health problem such as heart, lung, kidney or liver problems You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial You are pregnant or breastfeeding
  • Study start date : 16/11/2015
  • Study end date : 30/11/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Professor Maria Hawkins

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