Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
PDS (Primary Debulkdung Surgery): PDS with maximum effort to achieve the goal of complete gross resection
6 cycles of standard chemotherapy: 6 cycles of standard chemotherapy after Primary Debuling Surgery
Timing of surgery after 3 cycles of standard NACT, IDS: Timing of surgery after 3 cycles of standard NACT
IDS: IDS with maximum effort to achieve the goal of complete gross resection after NACT
3 cycles of standard chemotherapy: 3 more cycles (for a total of 6) of standard chemotherapy after IDS
Study 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.
Eligibility
Primary outcome measure(s)
- overall survival (OS) — Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
To compare the overall survival (OS) after primary debulking surgery (PDS) versus interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) in patients with FIGO (2014) stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma. The primary endpoint overall survival time is calculated from the date of randomization until the date of death from any cause or date of last contact (censored observation).
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Medical University of Vienna | Vienna | Austria | |
| University Hospital, Rigshospitalet | Copenhagen | Denmark | |
| Institut Bergonié | Bordeaux | France | |
| Hôpital Européen Georges Pompidou (HEGP) | Paris | France | |
| Institute Gustave Roussy | Villejuif | France | |
| Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie | Berlin | Germany | |
| Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe | Dresden | Germany | |
| Kaiserswerther Diakonie; Florence-Nightingale-Hospital | Düsseldorf | Germany | |
| Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie | Essen | Germany | |
| Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie | Hamburg | Germany | |
| Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München | München | Germany | |
| Klinikum rechts der Isar, Frauen- und Poliklinik | München | Germany | |
| Universitätsklinikum Tübingen | Tübingen | Germany | |
| European Institute of Oncology; Gynecologic Cancer Surgery | Milan | Italy | |
| Fondazione IRCCS Istituto Nazionale Tumori - Milan | Milan | Italy | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli | Naples | Italy | |
| Skane University Hospital | Lund | Sweden | |
| Karolinska University Hospital | Solna | Sweden | |
| Imperial College London, Hammersmith Hospital, Surgery&Cancer | London | United Kingdom |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02828618 on ClinicalTrials.gov ↗ ← All trials in Denmark