🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT02828618
Active, not recruiting Not applicable

Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

NCT02828618 · tracked via the Priya Life Science Germany tracker
Sponsor
AGO Study Group
Phase
Not applicable
Started
2016-07
Last updated
2025-10-03

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

PDS (Primary Debulkdung Surgery)6 cycles of standard chemotherapyTiming of surgery after 3 cycles of standard NACT, IDSIDS3 cycles of standard chemotherapy

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis) * Females aged ≥ 18 years * Patients who have given their written informed consent * Good performance status (ECOG 0/1) * Good ASA score (1/2) * Preoperative CA 125/CEA ratio ≥ 25 (if CA-125 is elevated)\* * If \<25 and/or biopsy with non-serous, non-endometroid histology, esophago-gastro-duodenoscopy (EGD) and colonoscopy mandatory to exclude gastrointestinal primary cancer * Assessment of an experienced surgeon, that based on all available information, the patient can undergo the procedure and the tumor can potentially be completely resected * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. * Platelet count ≥ 100 x 109/L. * Renal function: Serum-Creatinine ≤ 1.5 x institutional upper limit normal (ULN). * Hepatic function: * Bilirubin ≤ 1.5 x ULN. * SGOT ≤ 3 x ULN * Alkaline phosphatase ≤ 2.5 x ULN. * Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1. Exclusion Criteria: * Non epithelial ovarian malignancies and borderline tumors * Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity. * Recurrent ovarian cancer * Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy * Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis * Clinical relevant dysfunctions of blood clotting (including drug induced) * Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator) * Pregnancy * Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent * Any reasons interfering with regular follow-up

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
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

More AGO Study Group trials in Germany

Other trials for the same condition

Official registry record

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 Germany