TRUST: Trial of radical upfront surgical therapy in advanced ovarian cancer (ENGOT ov33 / AGO‐OVAR OP7).

Authors

Sven Mahner

Sven Mahner

Department for Gynecology and Obstetrics, University of Munich, Munich, Germany

Sven Mahner , Florian Heitz , Alexander Burges , Alexander Reuss , Bernhard Kraemer , Barbara Schmalfeldt , Jalid Sehouli , Bjoern Lampe , Andreas Schnelzer , Pauline Wimberger , Christina Fotopoulou , Frederic Guyon , Fabrice Lecuru , Denis Querleu , Stefano Greggi , Nicoletta Colombo , Giovanni Damiano Aletti , Philipp Harter , Andreas Du Bois

Organizations

Department for Gynecology and Obstetrics, University of Munich, Munich, Germany, Department of Gynecologic Oncology, Kliniken Essen-Mitte, Essen, Germany, AGO and Department of Gynecology, University Hospital Munich-Großhadern, Munich, Germany, AGO and Coordinating Center for Clinical Trials, Marburg, Germany, University of Tuebingen, Department of Gynecology and Obstetrics, Tübingen, Germany, AGO and Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, AGO and Charité Campus Virchow-Klinikum, Berlin, Germany, Florence Nightingale Hospital, Düsseldorf, Germany, Department of Gynecology, Klinikum rechts der Isar der Technischen Universität, Munich, Germany, Department of Gynecology and Obstetrics, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany, Imperial College London, London, United Kingdom, GINECO and Institut Bergonié, Bordeaux, France, GINECO and European Georges Pompidou Hospital, Paris, France, Institut Claudius Regaud, IUCT-Oncopole, CRCT, Inserm, Toulouse, France, MITO and Istituto Nazionale Dei Tumori, Naples, Italy, University of Milano-Bicocca and Istituto Europeo di Oncologia, Milan, Italy, Mayo Clinic, Rochester, MN, Departments of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany, AGO and Kliniken Essen Mitte, Essen, Germany

Research Funding

Other

Background: Primary cytoreductive surgery (PDS) followed by chemotherapy has been considered as standard management for advanced ovarian cancer patients (pts) over decades. An alternative approach of interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) was subsequently reported by two randomized phase III trials (EORTC‐GCG, CHORUS). Owing to important limitations of these studies, especially regarding surgical quality, optimal timing of surgical therapy in advanced ovarian cancer is still unclear. Methods: TRUST is an international open, randomized, controlled multicenter trial investigating overall survival (OS; primary endpoint) after PDS vs NACT and subsequent IDS in pts with FIGO stage IIIB‐IVB ovarian, tubal, and peritoneal carcinoma. Secondary objectives are safety of complete tumor resection, progression‐free survival and quality of life (QoL) as well as surgical morbidity. In order to guarantee adequate surgical quality, participating centers need to fulfill specific quality assurance criteria (e.g. ≥50% complete resection rate in upfront surgery for FIGO IIIB-IV pts, ≥36 debulking-surgeries/year) and agree to independent audits by TRUST Quality committee delegates. A 1:1 randomization to PDS or NACT followed by IDS stratified by center and age‐ECOG combination (ECOG 0 and age ≤65 years vs ECOG > 0 or age > 65 years) is performed. Pts in the PDS arm will undergo surgery followed by 6 cycles of platinum-based chemotherapy, whereas pts in the IDS arm will be treated with 3 cycles of NACT after histologic confirmation of the disease, followed by IDS and subsequently 3 cycles of platinum-based chemotherapy. Intention of surgery for both groups will be complete tumor resection as per guideline recommendations. Health related QoL will be assessed using the EORTC QLQ‐C30, QLQ‐OV28, and EQ‐5D‐3L questionnaires. For sample size planning, we considered a prolongation of median OS from 45 months in the IDS arm to 60 months in the PDS arm (HR 0.75) as clinically relevant. 380 events are needed to obtain a power of 80% in two‐sided log-rank test with significance level of 0.05. The primary analysis will be done in the ITT‐population of 686 randomized pts. By Feb 3 2017, 46 pts were randomized. Clinical trial information: NCT02828618

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT02828618

Citation

J Clin Oncol 35, 2017 (suppl; abstr TPS5602)

DOI

10.1200/JCO.2017.35.15_suppl.TPS5602

Abstract #

TPS5602

Poster Bd #

423a

Abstract Disclosures