A study looking at ways to predict how well chemotherapy for ovarian cancer will work (CTCR-OV03)

Please note this trial is no longer recruiting patients.

This study is using MRI scans and blood and tissue samples to help predict the outcome of chemotherapy for cancer of the ovary.

Doctors usually treat cancer of the ovary with combinations of surgery and chemotherapy. But they cannot always say how well the treatment will work. Doctors don’t want to put people through long courses of treatment and side effects if it won’t help them. If they could develop a test to predict outcome, doctors could work out which treatment will work best for a particular person.

Researchers want to see if they can tell in advance how well chemotherapy for ovarian cancer will work. They will take MRI scans before, during and after the course of chemotherapy. They will also collect blood and tissue samples. They will look at the genes in the tissue samples, the number of cancer cells in the blood, and the MRI scan results. They will see if there is a link between this information and how well the chemotherapy works. The aim of this study is to bring all these methods together to try and predict how well ovarian cancer will respond to chemotherapy.

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.

Recruitment

Start 16/08/2006

End 28/09/2011

Phase

Phase 1

Who can enter

You can enter this study if you

Have ovarian cancer (including primary peritoneal cancer and fallopian tube cancer) that has spread outside your pelvis into your abdomen (stage 3), or into other body organs (stage 4) OR
Have ovarian cancer that has grown outside your ovaries (stage 2), and your doctor can detect a collection of fluid (ascites) or a lump in your lower tummy area (your pelvis)
Have cancer that can be measured on a scan
Can have chemotherapy before surgery to remove any remaining cancer left behind after your first operation
Are able to have MRI scans
Are well enough to take part (performance status 0, 1 or 2)

Trial design

This study will recruit 25 people. Everyone in the study will be due to start chemotherapy before their interval debulking surgery (IDS). You will have the tests and hospital visits that are standard for this course of treatment. You will also have some extra tests as part of the study.

Before your chemotherapy starts, and 3 times throughout treatment, you will have an MRI scan of your tummy area (abdomen and pelvis). You will have an injection of dye that helps to show up the ovaries during the scan. Each scan will take about an hour.

When you have your routine laparoscopy, the research team will take some extra samples of tissue, and fluid called ascites. They will store these samples and later compare them with your MRI scan results.

During your debulking surgery, the surgeon will take more samples of cancer, healthy tissue, and any fluid (ascites) they may find.

The research team will take 5 extra blood samples throughout your course of chemotherapy. And collect samples of any extra abdominal fluid (ascites) that you may need to have drained while you are on the study.

Hospital visits

Most of the study procedures will take place during your routine visits for your ovarian cancer treatment. But you will need to make extra hospital visits for your 4 study MRI scans

Before you start chemotherapy
After your first cycle of chemotherapy
After your 3rd cycle of chemotherapy, before you have your interval debulking surgery (IDS)
After your course of chemotherapy is complete