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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004429-45-GB

Enrollment

400

Registered

2007-10-15

Start date

2008-02-04

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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:

Interventions

Trade Name: Carboplatin Product Name: Carboplatin Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CARBOPLATIN CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of neoadjuvant chemotherapy i.e. chemotherapy given before and after primary surgery compared to standard surgery followed by chemotherapy;Secondary Objective: To evaluate overall (OS) and progression-free survival (PFS), safety and patient reported outcomes of quality of life (QoL).;Primary end point(s): Overall survival	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026