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
earlier with chemotherapy can improve survival and quality of life for
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
in this group will continue
to have their levels of CA125 monitored and are given chemotherapy when
develop symptoms or reappearance of cancer is detected by physical
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.
|Type of study:||Randomised trial|
|Study start date:||August 1997|
|Study end date:||December 2008|
|Registrations achieved:||1442, as of August 2005|
|Randomisations achieved:||425, as of December 2007|
|Also included in this study:||Health Economics|
Quality of life outcomes
NHS Information Centre flagging
|Chief investigator:||Prof. Gordon Rustin|
- Histologically confirmed epithelial ovarian, fallopian tube
or primary serous peritoneal carcinoma
- In complete remission with a normal CA 125 since first-line
- A normal CA 125 result within 4 weeks of registration onto
- 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
- 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|
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