A randomised feasibility trial to determine the impact of timing of surgery and chemotherapy in newly diagnosed patients with advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma

Not Applicable

Completed

• Conditions: Advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma; Cancer; Ovarian, primary peritoneal, or fallopian tube carcinoma

• Registration Number: ISRCTN74802813
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26002111 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-25
• Study Completion: 2010-08-30
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

1. Clinical and imaging evidence of a pelvic mass with extrapelvic metastatic disease at presentation
2. Randomisation should be carried out within 4 weeks of obtaining clinical and imaging evidence of disease
3. Serum Cancer Antigen (CA 125) / CarcinoEmbryonic Antigen (CEA) ratio >25 (if the serum CA 125/CEA is less than or equal to 25 and the serum CEA is above the upper limit of normal, the patient should undergo investigations to exclude gastrointestinal cancer)
4. Patient planned to receive carboplatin-based chemotherapy
5. Patient fit to undergo protocol treatment and follow-up
6. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons
7. Written informed consent of the patient

Exclusion Criteria

N/A

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
<br> 1. Progression-free survival<br> 2. Quality of life<br>