Status:
NOT_YET_RECRUITING
Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)
Lead Sponsor:
Shanghai Gynecologic Oncology Group
Collaborating Sponsors:
Obstetrics & Gynecology Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
OBJECTIVES: Compare the efficacy and safety in patients with advanced ovarian cancer treated with NACT-IDS versus PDS, among different tumor burden groups. Compare survival benefit of PARPi therapy in...
Eligibility Criteria
Inclusion
- For Part 1:
- 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.
Exclusion
- Non-epithelial ovarian malignancies and borderline tumors.
- Low grade ovarian cancer.
- Mucinous ovarian cancer.
- cPCI score \> 8.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
- 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:
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT04515602
Start Date
January 1 2021
End Date
January 1 2028
Last Update
August 27 2020
Active Locations (4)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
2
Obstetrics & Gynecology Hospital of Fundan University
Shanghai, China
3
Shanghai First Maternity and Infant Hospital
Shanghai, China
4
Shanghai Jiao Tong University School of Medicine Xinhua Hospital
Shanghai, China