Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Gynecologic Oncology Group
About this trial
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 criteria
Qualifiers
Females aged ≥ 18 years.
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.
Disqualifiers
Non-epithelial ovarian malignancies and borderline tumors.
Low grade ovarian cancer.
Mucinous ovarian cancer.
cPCI score > 8.
Trial design
Treatments tested in this trial
- Primary debulking surgery
- Neoadjuvant chemotherapy
- PARPi
Treatment groups
410 Participants
are divided into 4 treatment groupsSponsors and collaborators
Shanghai Gynecologic Oncology Group
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
Source ClinicalTrials.gov