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This is a trial for women with recurrent ovarian, fallopian tube or primary peritoneal cancer, whose disease has been shrunk by chemotherapy. The study will address whether such patients may benefit from maintenance treatment with two new anti-cancer drugs called olaparib and cediranib.
About the trial
ICON9 is a randomised study and patients will be randomly allocated to receive one or both of the anti-cancer drugs on completion of their chemotherapy (called maintenance treatment). Patients will be in the study for up to 6 years and will continue taking the study tablets until their study doctor thinks they are no longer helping to control the disease. Study tablets may also be discontinued by the study doctor if patients experience side effects that have a negative impact on their quality of life.
ICON9 aims to find out if one or both anticancer drugs taken as maintenance treatment can effectively control the regrowth of ovarian cancer following a good response to chemotherapy. Maintenance therapy is the treatment of cancer with medication, typically following an initial round of treatment. Maintenance treatment may include chemotherapy, hormone therapy, or targeted therapy. Maintenance therapy is used to avoid or slow the growth/return of cancer after initial treatment.
Who can take part?
This trial is for women with ovarian cancer that has responded to platinum based treatment (platinum sensitive). Patients with platinum sensitive disease are defined as those who have been off therapy for greater than 6 months after achieving a response to platinum-based first-line therapy such as carboplatin or cisplatin. The trial is for women with recurrent ovarian, fallopian tube or primary peritoneal cancer, whose disease has been shrunk by chemotherapy.
You will have some routine investigations to assess your response to the chemotherapy you are currently having. These will include blood tests (including CA125, kidney and thyroid function), a urine test and a CT or MRI scan of your abdomen and pelvis. You may also have a chest x-ray or a CT scan of your chest. These investigations, which are performed as part of your routine care, will be used as part of the screening process to determine if the ICON9 study is suitable for you.