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)
overall survival (OS) — 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).
Trial sites (20)
Facility
City
Region
Status
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
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.
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