Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

NCT02828618 | Active Not Recruiting DMC

• 1 other identifier: AGO-OVAR OP.7/TRUST
• Study Type: interventional
• Target: 797
• Locations: 8 countries
• Sites: 20

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  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).

  Patients will be followed up for a minimum of 5 years after registration/randomisation or until death

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Patients will be followed up for a minimum of 5 years after registration/randomisation or until death

• Progression-free survival 2 (PFS2)

  Patients will be followed up for a minimum of 5 years after registration/randomisation or until death

• Time to first subsequent anticancer therapy or death (TFST)

  Patients will be followed up for a minimum of 5 years after registration/randomisation or until death

• Time to second subsequent anticancer therapy or death (TSST)

  Patients will be followed up for a minimum of 5 years after registration/randomisation or until death

• Quality of life (QoL)

  Patients will be followed up for a minimum of 5 years after registration/randomisation or until death

Study Arms (2)

Arm I PDS and chemotherapy

ACTIVE COMPARATOR

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); Procedure: 6 cycles of standard chemotherapy

Arm II Timing of surgery after 3 cycles of SOC CTX

EXPERIMENTAL

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; Procedure: IDS; Drug: 3 cycles of standard chemotherapy

Interventions

PDS (Primary Debulkdung Surgery) PROCEDURE

PDS with maximum effort to achieve the goal of complete gross resection

Arm I PDS and chemotherapy

6 cycles of standard chemotherapy PROCEDURE

6 cycles of standard chemotherapy after Primary Debuling Surgery

Arm I PDS and chemotherapy

Timing of surgery after 3 cycles of standard NACT, IDS PROCEDURE

Timing of surgery after 3 cycles of standard NACT

Arm II Timing of surgery after 3 cycles of SOC CTX

IDS PROCEDURE

IDS with maximum effort to achieve the goal of complete gross resection after NACT

Arm II Timing of surgery after 3 cycles of SOC CTX

3 cycles of standard chemotherapy DRUG

3 more cycles (for a total of 6) of standard chemotherapy after IDS

Arm II Timing of surgery after 3 cycles of SOC CTX

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AGO Study Group: lead

Study Sites (20)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Medical University of Vienna

Vienna, A-1090, Austria

Location

University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Institut Bergonié

Bordeaux, France

Location

Hôpital Européen Georges Pompidou (HEGP)

Paris, France

Location

Institute Gustave Roussy

Villejuif, 94805, France

Location

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie

Berlin, 13353, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe

Dresden, 01307, Germany

Location

Kaiserswerther Diakonie; Florence-Nightingale-Hospital

Düsseldorf, Germany

Location

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie

Essen, 45136, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie

Hamburg, 20246, Germany

Location

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München

München, 81377, Germany

Location

Klinikum rechts der Isar, Frauen- und Poliklinik

München, 81675, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

European Institute of Oncology; Gynecologic Cancer Surgery

Milan, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori - Milan

Milan, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli

Naples, Italy

Location

Skane University Hospital

Lund, 22185, Sweden

Location

Karolinska University Hospital

Solna, 17176, Sweden

Location

Imperial College London, Hammersmith Hospital, Surgery&Cancer

London, W12 OHS, United Kingdom

Location

Related Publications (1)

• Reuss A, du Bois A, Harter P, Fotopoulou C, Sehouli J, Aletti G, Guyon F, Greggi S, Mosgaard BJ, Reinthaller A, Hilpert F, Schade-Brittinger C, Chi DS, Mahner S. TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7). Int J Gynecol Cancer. 2019 Oct;29(8):1327-1331. doi: 10.1136/ijgc-2019-000682. Epub 2019 Aug 15.

  PMID: 31420412 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sven Mahner, Professor MD

  AGO Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

DK (1); DE (8); SE (2); GB (1); AU (1); FR (3); US (1); IT (3)