Clinical trial · Interventional
Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
NCT02828618CI-TRIAL-00096221TRUSTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 cycles of standard chemotherapy | Drug | — | UNRESOLVED |
| 6 cycles of standard chemotherapy | Procedure | — | UNRESOLVED |
| IDS | Procedure | — | UNRESOLVED |
| PDS (Primary Debulkdung Surgery) | Procedure | — | UNRESOLVED |
| Timing of surgery after 3 cycles of standard NACT, IDS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I PDS and chemotherapy
- description
- PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy
- interventionNames
- Procedure: PDS (Primary Debulkdung Surgery)
- Procedure: 6 cycles of standard chemotherapy
- type
- EXPERIMENTAL
- label
- Arm II Timing of surgery after 3 cycles of SOC CTX
- description
- 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
- interventionNames
- Procedure: Timing of surgery after 3 cycles of standard NACT, IDS
- Procedure: IDS
- Drug: 3 cycles of standard chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDFumagalli D, Jayraj A, Olearo E, Capasso I, Hsu HC, Tzur Y, Piedimonte S, Jugeli B, Santana BN, De Vitis LA, Caruso G, Aletti G, Colombo N, Ramirez PT. Primary versus interval cytoreductive surgery in patients with rare epithelial or non-epithelial ovarian cancer. Int J Gynecol Cancer. 2025 Mar;35(3):101664. doi: 10.1016/j.ijgc.2025.101664. Epub 2025 Jan 28. PMID 40022844
- DERIVEDReuss 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