Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

Korábbi kezelés

• Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
• Clinical relevant dysfunctions of blood clotting (including drug induced)

Más betegség

• 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
• Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent

Életkor

• Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)

Egyéb

• Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis
• Pregnancy
• Any reasons interfering with regular follow-up

• 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.