A randomised 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 - CHORUS

Phase 1

• Conditions: Women with newly diagnosed, suspected, advanced (compatible with FIGO stage III/IV) ovarian, primary peritoneal or fallopian tube cancer who fulfil other entry criteria, with clinical and/or imaging evidence of extrapelvic metastatic disease at presentation and serum CA 125/CEA ratio > 25; MedDRA version: 9.1 Level: LLT Classification code 10033131 Term: Ovarian carcinoma; MedDRA version: 9.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma; MedDRA version: 9.1 Level: LLT Classification code 10016180 Term: Fallopian tube cancer

• Registration Number: EUCTR2007-004429-45-GB
• Lead Sponsor: Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-15
• Study Completion: 2014-10-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 550

Inclusion Criteria

Clinical and/or imaging evidence of a pelvic mass with extra-pelvic metastatic disease (compatible with FIGO stage III/IV) at presentation. Randomisation should be carried out within 4 weeks after obtaining clinical and/or imaging evidence of disease.
Serum CA 125/CEA ratio > 25 [if the serum CA 125/CEA ? 25 and the serum CEA is above the upper limit of normal, the patient should undergo investigations to exclude gastrointestinal cancer]
Patient planned to receive carboplatin-based chemotherapy
Patient fit to undergo protocol treatment and follow-up
No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons. Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago with no evidence of subsequent recurrence.
Written informed consent of the patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified