Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

AGO-OVAR OP.7/TRUST

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.

2016-07-01

2024-12-01

2025-02-01

Active (not recruiting)

797

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 797, 'type': 'ACTUAL'}}

2024-05-09