Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)

Korábbi kezelés

• Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
• Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.

Más betegség

• Non-epithelial ovarian malignancies and borderline tumors.
• Low grade ovarian cancer.
• Mucinous ovarian cancer.
• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
• Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
  • For Part 2:
• Non-epithelial ovarian malignancies and borderline tumors.
• Low grade ovarian cancer.
• Mucinous ovarian cancer.
• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
• Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

Egyéb

• cPCI score \> 8.
• Clear cell carcinoma.
• cPCI score \< 8.
• Lung metastasis, diffused pleural metastasis, bone metastasis, metastasis of mediastinal lymph node, internal mammary node, or multiple extra-peritoneal lymph nodes.

• Females aged ≥ 18 years.
• Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or core needle biopsy\*, laparoscopic biopsy is not recommended). \* If core needle biopsy could not be performed, patients should satisfy the following conditions:
  • the patient has a pelvic mass, and
  • omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis (FIGO IV), and
  • preoperative CA125/CEA ratio \> 25. If CA125/CEA ratio ≤ 25, imaging or endoscopy is obligatory to exclude a primary gastric, colon, or breast carcinoma.
• cPCI score ≤ 8.
• Performance status (ECOG 0-2).
• Good ASA score (1/2).
• Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
  • white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
  • serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
  • serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
• Comply with the study protocol and follow-up.
• Patients who have given their written informed consent.
• Females aged ≥ 18 years, and \< 70 years.
• Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
• cPCI score ≥ 10.
• For FIGO IVB patients, abdominal lesions should be confined to one lobe of liver parenchyma metastasis or splenic metastasis. All extra-abdominal metastases should be resectable, such as inguinal lymph nodes, solitary supraclavicular, retrocrural or paracardial nodes.
• Good performance status (ECOG 0-1).
• Good ASA score (1/2).
• Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery.
• Comply with the study protocol and follow-up.
• Patients who have given their written informed consent.

A regiszterben nem jelölt feltételek

• For Part 1: