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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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16 October 2017 |
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Main ID: |
ISRCTN75843298 |
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Date of registration:
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01/07/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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North Thames CA125 study in advanced ovarian cancer
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Scientific title:
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North Thames CA125 study in advanced ovarian cancer: a randomised controlled trial |
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Date of first enrolment:
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05/12/1989 |
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Target sample size:
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237 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN75843298 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Email:
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Affiliation:
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Name:
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically confirmed diagnosis of invasive epithelial ovarian carcinoma
2. International Federation of Gynaecology and Obstetrics (FIGO) stage Ic, II, III or IV
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. Aged 18 - 75 years
5. Adequate renal, hepatic and bone marrow function
6. Life expectancy of at least 3 months
7. No history of previous malignancy, except basal cell carcinoma of the skin or in situ carcinoma of the cervix
8. No medical contra-indications to protocol treatments
Exclusion criteria: Does not comply with above inclusion criteria.
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian cancer
Cancer
Ovarian cancer
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Intervention(s)
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Patients are randomised to one of two treatment schedules:
1. Schedule A: Carboplatin or cisplatin repeated every four weeks for a total of five courses. CA125 measurement to be carried out prior to each course.
2. Schedule B: Carboplatin or cisplatin repeated every four weeks for a total of eight courses. CA125 measurement to be carried out prior to each course.
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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