A randomised trial in relapsed ovarian cancer, early treatment based on Cancer Antigen (CA) 125 levels alone versus delayed treatment based on conventional clinical factors

Not Applicable

Completed

• Conditions: Cancer; Ovarian

• Registration Number: ISRCTN87786644
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20888993

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-04-06
• Study Completion: 2005-12-31
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

1. Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal carcinoma
2. In complete remission with a normal CA125 since first-line platinum containing chemotherapy
3. A normal CA125 result within 4 weeks of registration onto the trial
4. Patient in confirmed remission (based on physical gynaecological examination) within 6 weeks of registration onto the trial
5. Able to attend regular follow-up and have regular blood tests
6. Local laboratory able to blind CA125 results from clinicians
7. No concomitant or previous malignancy within 5 years which is likely to interfere with the protocol treatments or comparisons, except with concomitant or previous non-melanoma skin cancer
8. Informed consent from the patient

Exclusion Criteria

Previous malignancy within 5 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time

Secondary Outcome Measures

Name	Time	Method
1. Quality of life<br>2. Health Economics