A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

Who is this study for? Patients with Ovarian Cancer
What treatments are being studied? PARP Inhibitor
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Females aged ≥ 18 years.

• Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma

• Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination

• Complete cytoreduction can be achieved based on CT or PET/CT examination

• Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing

• Performance status (ECOG 0-2)

• 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.

Locations
Other Locations
China
The First People's Hospital of Foshan
RECRUITING
Foshan
Sun Yet-Sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Fudan University Cancer Hospital
RECRUITING
Shanghai
Obstetrics and Gynecology Hospital of Fundan University
RECRUITING
Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Libing Xiang
xiang.libing@zs-hospital.sh.cn
86 21 64041990
Backup
Rong Jiang
jiang.rong@zs-hospital.sh.cn
86 21 64041990
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2027-06
Participants
Target number of participants: 220
Treatments
Experimental: Upfront cytoreductive surgery with maintenance therapy
Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
Active_comparator: Neoadjuvant chemotherapy with maintenance therapy
Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
Related Therapeutic Areas
Sponsors
Leads: Shanghai Gynecologic Oncology Group
Collaborators: Fudan University

This content was sourced from clinicaltrials.gov