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NCT02828618 · ClinicalTrials.gov registry record · NA
Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
A NA study of Ovarian Cancer, sponsored by AGO Study Group.
- Active
- Registry status
- NA
- Development phase
- 797
- Enrollment target
- 20
- Study locations
NCT02828618: Active NA study of Ovarian Cancer, sponsored by AGO Study Group.
NCT02828618 is a NA study of Ovarian Cancer that is active but no longer recruiting, run by AGO Study Group. The registered enrollment target is 797 participants, above the 726-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02828618, a NA study of Ovarian Cancer, is active but no longer recruiting, sponsored by AGO Study Group.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 797 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Interventions
- PROCEDURE PDS (Primary Debulkdung Surgery)
- PROCEDURE 6 cycles of standard chemotherapy
- PROCEDURE Timing of surgery after 3 cycles of standard NACT, IDS
- PROCEDURE IDS
- DRUG 3 cycles of standard chemotherapy
Study Locations (20)
Other
- Medical University of Vienna - Vienna
- University Hospital, Rigshospitalet - Copenhagen
- Institut Bergonié - Bordeaux
- Hôpital Européen Georges Pompidou (HEGP) - Paris
- Institute Gustave Roussy - Villejuif
- Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie - Berlin
- Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe - Dresden
- Kaiserswerther Diakonie; Florence-Nightingale-Hospital - Düsseldorf
- Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie - Essen
- Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie - Hamburg
- Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München - München
- Klinikum rechts der Isar, Frauen- und Poliklinik - München
- Universitätsklinikum Tübingen - Tübingen
- European Institute of Oncology; Gynecologic Cancer Surgery - Milan
- Fondazione IRCCS Istituto Nazionale Tumori - Milan - Milan
- Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli - Naples
- Skane University Hospital - Lund
- Karolinska University Hospital - Solna
- Imperial College London, Hammersmith Hospital, Surgery&Cancer - London
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 797 participants |
| Start Date | 2016-07 |
| Est. Completion | 2025-12 |
| Phase | NA |
What the registry record for NCT02828618 still lists
NCT02828618 is an interventional study that assigns participants to a tested intervention. The registered 797 participants enrollment target is mid-sized for trials with a published cap, above the 726-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which PDS (Primary Debulkdung Surgery) is the first listed.
NCT02828618 names 20 study sites across 2 states, led by Other, New York.
Frequently Asked Questions
What is clinical trial NCT02828618 about?
NCT02828618 is a clinical study titled "Trial on Radical Upfront Surgery in Advanced Ovarian Cancer". 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 w...
What is the current status of trial NCT02828618?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 797 participants. The study started on 2016-07. Estimated completion is 2025-12.
What conditions does trial NCT02828618 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT02828618?
The interventions under investigation include: PDS (Primary Debulkdung Surgery) (PROCEDURE), 6 cycles of standard chemotherapy (PROCEDURE), Timing of surgery after 3 cycles of standard NACT, IDS (PROCEDURE), IDS (PROCEDURE), 3 cycles of standard chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02828618?
This trial is sponsored by AGO Study Group, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02828618 being conducted?
This trial has 20 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02828618's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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