Starting soon
Phase 3
Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)
Condition(s) studied
Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
Investigational drug(s) / intervention(s)
Primary debulking surgeryNeoadjuvant chemotherapyPARPi
Primary debulking surgery: Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
Neoadjuvant chemotherapy: 3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
PARPi: For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.
Study summary
The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.
Eligibility
For Part 1:
Inclusion Criteria:
1. Females aged ≥ 18 years.
2. 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:
1. the patient has a pelvic mass, and
2. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis (FIGO IV), and
3. preoperative CA125/CEA ratio \> 25. If CA125/CEA ratio ≤ 25, imaging or endoscopy is obligatory to exclude a primary gastric, colon, or breast carcinoma.
3. cPCI score ≤ 8.
4. Performance status (ECOG 0-2).
5. Good ASA score (1/2).
6. Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
1. white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
2. 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,
3. serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
7. Comply with the study protocol and follow-up.
8. Patients who have given their written informed consent.
Exclusion Criteria:
1. Non-epithelial ovarian malignancies and borderline tumors.
2. Low grade ovarian cancer.
3. Mucinous ovarian cancer.
4. cPCI score \> 8.
5. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
6. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
7. 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:
Inclusion Criteria:
1. Females aged ≥ 18 years, and \< 70 years.
2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
3. cPCI score ≥ 10.
4. 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.
5. Good performance status (ECOG 0-1).
6. Good ASA score (1/2).
7. Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery.
8. Comply with the study protocol and follow-up.
9. Patients who have given their written informed consent.
Exclusion Criteria:
1. Non-epithelial ovarian malignancies and borderline tumors.
2. Low grade ovarian cancer.
3. Mucinous ovarian cancer.
4. Clear cell carcinoma.
5. cPCI score \< 8.
6. Lung metastasis, diffused pleural metastasis, bone metastasis, metastasis of mediastinal lymph node, internal mammary node, or multiple extra-peritoneal lymph nodes.
7. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
8. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
9. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Primary outcome measure(s)
- Overall survival — Participants will be followed for at least 5 years after randomization
Time from randomization to the date of death from any cause or date of last contact
Trial sites (4)
| Facility | City | Region | Status |
|---|
| Zhongshan Hospital Fudan University |
Shanghai |
Shanghai Municipality |
|
| Obstetrics & Gynecology Hospital of Fundan University |
Shanghai |
China |
|
| Shanghai First Maternity and Infant Hospital |
Shanghai |
China |
|
| Shanghai Jiao Tong University School of Medicine Xinhua Hospital |
Shanghai |
China |
|
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