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OV05: Early Treatment Based on CA 125 Levels Alone versus Delayed Treatment Based on Conventional Clinical Indicators
Is it more effective to give chemotherapy when CA125 starts to rise?

  • What is this study about?

    Ovarian cancer is the fourth most common cancer in women. Treatment involves surgery to remove the cancer, followed by chemotherapy. Many women have a good response to chemotherapy, but in some women the cancer does return.

    This trial is investigating the best time to give chemotherapy to women who have recurring ovarian cancer with raised levels of CA125. It is hoped that treating patients earlier with chemotherapy can improve survival and quality of life for women with ovarian cancer.

    In this study, women who have raised marker will be randomly placed into two groups: in one group women will receive chemotherapy immediately when they have no symptoms. In the second group treatment is delayed. Patients in this group will continue to have their levels of CA125 monitored and are given chemotherapy when they develop symptoms or reappearance of cancer is detected by physical examination.

  • Who is included?

    Women who have either ovarian, fallopian tube or primary peritoneal cancer who has complete remission with a normal CA125 marker after first line chemotherapy treatment

  • When is it taking place?

    The trial completed recruitment of over 1400 women in October 2005.

  • Where is it taking place?

    Many hospitals throughout Europe, Russia and South Africa are taking part.

  • Who is funding the study?

    The trial is supported by the Medical Research Council and the National Cancer Research Network.

  • Contact details

    ov05@ctu.mrc.ac.uk

  • Further Information

    Type of study:Randomised trial
    Status:Closed
    Study start date:August 1997
    Study end date:December 2008
    Registration target:1442
    Registrations achieved:1442, as of August 2005
    Randomisation target:650
    Randomisations achieved:425, as of December 2007
    Also included in this study:Health Economics
    Quality of life outcomes
    Consumer involvement
    NHS Information Centre flagging
    Chief investigator:Prof. Gordon Rustin
    Sponsor:MRC
    Registration numbers:ISRCTN:87786644
    Inclusion criteria:
    • Histologically confirmed epithelial ovarian, fallopian tube or primary serous peritoneal carcinoma
    • In complete remission with a normal CA 125 since first-line platinum-containing chemotherapy
    • A normal CA 125 result within 4 weeks of registration onto OV05
    • Patient in confirmed remission (based on physical and gynaecological examination) within 6 weeks of registration onto OV05
    • The patient must not have participated in ICON1 (adjuvant chemotherapy for early stage ovarian cancer)
    • Patients participating in ICON2 (carboplatin vs CAP in advanced disease), ICON3 (paclitaxel with carboplatin in first-line chemotherapy for advanced disease) and ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy) are eligible
    • Able to attend regular follow-up and have regular blood tests
    • Local laboratory is able to blind CA 125 results from clinician and is willing to participate in an approved quality assurance scheme (see Appendices A and B)
    • No active or previous malignancy within 5 years which is likely to interfere with the protocol treatments or comparisons, except for patients with concomitant or previous non-melanoma skin cancer.
    • Informed consent of the patient
    Exclusion criteria:None
    Intervention and control groups:Other
    Method of randomisation:n/a