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Trial on Radical Upfront Surgery in Advanced Ovarian Cancer (TRUST)

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ClinicalTrials.gov Identifier: NCT02828618
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
AGO Study Group

Brief 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer 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 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Active Comparator: Arm I PDS and chemotherapy
PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy
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

Experimental: Arm II Timing of surgery after 3 cycles of SOC CTX
3 cycles of standard NACT followed by IDS with maximum effort to achieve the goal of complete gross resection followed by 3 more cycles (for a total of 6) of standard chemotherapy
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




Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 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).



Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death ]
    Progression-free survival time is calculated from the date of randomization until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation). Progressive disease is defined as clinical or imaging-detected tumor progression or death in cases without prior documented tumor progression.

  2. Progression-free survival 2 (PFS2) [ Time Frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death ]
    PFS2 time is calculated from the date of randomization until the date of second progressive disease or death, whichever occurs first or date of last contact (censored observation).

  3. Time to first subsequent anticancer therapy or death (TFST) [ Time Frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death ]
    Time to first subsequent anticancer therapy is calculated from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurs first or date of last contact (censored observation). Maintenance treatments following a cytostatic treatment are not considered separate treatment lines.

  4. Time to second subsequent anticancer therapy or death (TSST) [ Time Frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death ]
    Time to second subsequent anticancer therapy is calculated from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurs first or date of last contact (censored observation). Maintenance treatments following a cytostatic treatment are not considered separate treatment lines.

  5. Quality of life (QoL) [ Time Frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death ]
    Quality of life (QoL) as measured by EORTC QLQ-C30 (Version 3), EORTC QLQ-OV28, EQ-5D-3L

  6. Documentation of surgical complications [ Time Frame: Patients will be followed up for 1 year after surgery or until death ]
    Assessment of safety: documentation of surgical complications 28 days after surgery and 1 year after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828618


Contacts
Contact: Gabriele Elser +496118804670 office-wiesbaden@ago-ovar.de

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Austria
Medical University of Vienna Not yet recruiting
Vienna, Austria, A-1090
Denmark
University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
France
Institut Bergonié Recruiting
Bordeaux, France
Hôpital Européen Georges Pompidou (HEGP) Recruiting
Paris, France
Institute Gustave Roussy Recruiting
Villejuif, France, 94805
Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie Recruiting
Berlin, Germany, 13353
Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe Recruiting
Dresden, Germany, 01307
Kaiserswerther Diakonie; Florence-Nightingale-Hospital Recruiting
Dusseldorf, Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie Recruiting
Essen, Germany, 45136
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie Recruiting
Hamburg, Germany, 20246
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München Recruiting
München, Germany, 81377
Klinikum rechts der Isar, Frauen- und Poliklinik Recruiting
München, Germany, 81675
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany
Italy
European Institute of Oncology; Gynecologic Cancer Surgery Recruiting
Milano, Italy
Fondazione IRCCS Istituto Nazionale Tumori - Milan Recruiting
Milano, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli Recruiting
Naples, Italy
Sweden
Skane University Hospital Not yet recruiting
Lund, Sweden, 22185
Karolinska University Hospital Recruiting
Solna, Sweden, 17176
United Kingdom
Imperial College London, Hammersmith Hospital, Surgery&Cancer Recruiting
London, United Kingdom, W12 OHS
Sponsors and Collaborators
AGO Study Group
Investigators
Principal Investigator: Sven Mahner, Professor MD AGO Study Group

Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT02828618     History of Changes
Other Study ID Numbers: AGO-OVAR OP.7/TRUST
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type