Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
NCT02828618 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 797
Last updated 2025-10-03
Summary
This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.
All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.
TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.
Conditions
Interventions
- PROCEDURE
-
PDS (Primary Debulkdung Surgery)
PDS with maximum effort to achieve the goal of complete gross resection
- PROCEDURE
-
6 cycles of standard chemotherapy
6 cycles of standard chemotherapy after Primary Debuling Surgery
- PROCEDURE
-
Timing of surgery after 3 cycles of standard NACT, IDS
Timing of surgery after 3 cycles of standard NACT
- PROCEDURE
-
IDS
IDS with maximum effort to achieve the goal of complete gross resection after NACT
- DRUG
-
3 cycles of standard chemotherapy
3 more cycles (for a total of 6) of standard chemotherapy after IDS
Sponsors & Collaborators
-
AGO Study Group
lead OTHER
Principal Investigators
-
Sven Mahner, Professor MD · AGO Study Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2025-02-28
- Completion
- 2025-12-31
Countries
- United States
- Austria
- Denmark
- France
- Germany
- Italy
- Sweden
- United Kingdom
Study Locations
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