Actively Recruiting
Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in Advanced Ovarian Cancer Treatment: A Randomized Phase II Trial
Led by Shanghai Gynecologic Oncology Group · Updated on 2025-02-10
220
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Gynecologic Oncology Group
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the best timing for surgery combined with maintenance targeted therapy in treating advanced ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma. This Phase II trial aims to determine how surgery combined with either Bevacizumab or PARP inhibitors (PARPi) affects outcomes for patients with these advanced cancers, focusing on those with primarily diagnosed advanced epithelial ovarian cancer. The study compares two main treatment approaches. One group receives primary debulking surgery with maximal tumor removal within three weeks after biopsy, followed by at least six cycles of chemotherapy and maintenance therapy with PARPi or Bevacizumab depending on BRCA mutation status. The other group starts with three cycles of chemotherapy, then has interval debulking surgery within six weeks, followed by three more chemotherapy cycles and maintenance therapy based on their BRCA status. Maintenance involves Olaparib for BRCA-mutated patients and Bevacizumab for those without the mutation. Participants will be followed for at least three years after randomization to assess overall survival as the primary outcome. Additional measures include progression-free survival, post-operative complications, quality of life, treatment-free survival times, and patterns of relapse. The study involves regular monitoring through clinical evaluations and follow-up visits, ensuring adherence to treatment and study protocols throughout the observation period.
CONDITIONS
Brief Title
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Pathologically confirmed stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Tumor burden score (cPCI) of 12 or less based on pre-operative CT or PET/CT
- Expectation that complete cytoreduction can be achieved based on imaging
- Agreement to undergo BRCA and HRD genetic testing
- Performance status of 0 to 2 (ECOG scale)
- Adequate bone marrow, kidney, and liver function to receive chemotherapy and surgery
- Ability and willingness to comply with study procedures and follow-up
- Provided written informed consent
You will not qualify if you...
- Non-epithelial ovarian malignancies or borderline tumors
- Low grade or mucinous ovarian cancer
- Inability to achieve complete cytoreduction due to extensive metastases
- Known allergy to components of olaparib, bevacizumab, or their excipients
- Other malignancies within the past 5 years except certain in situ carcinomas and thyroid or breast cancer without relapse
- Medical conditions that prevent safe surgery or chemotherapy
- Factors interfering with informed consent, protocol compliance, or follow-up, including religious or psychological reasons
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 3 weeks after biopsy for primary surgery or up to 6 weeks after 3 cycles of chemotherapy for interval surgery
Participants undergo either primary debulking surgery with maximal cytoreduction or interval debulking surgery following neoadjuvant chemotherapy.
1 surgery visit and immediate post-operative care
Duration - At least 6 cycles of chemotherapy plus maintenance therapy duration varies based on response
Participants receive chemotherapy with Paclitaxel or Docetaxel plus Carboplatin in cycles before and/or after surgery, followed by maintenance therapy with PARP inhibitors for BRCA mutated patients or Bevacizumab for non-BRCA mutated patients after achieving complete or partial response.
Multiple chemotherapy cycles with visits every 3 weeks and maintenance therapy visits every 3 weeks or as prescribed
Duration - At least 3 years after randomization
Participants are monitored for post-operative complications, quality of life, survival, and relapse patterns.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 9 locations
1
The First People's Hospital of Foshan
Foshan, China
Actively Recruiting
2
Sun Yet-Sen University Cancer Center
Guangzhou, China
Actively Recruiting
3
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
4
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
5
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Actively Recruiting
6
Fudan University Cancer Hospital
Shanghai, China
Actively Recruiting
7
Obstetrics and Gynecology Hospital of Fundan University
Shanghai, China
Actively Recruiting
8
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
9
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
L
Libing Xiang
R
Rong Jiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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