Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
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.
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.
For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.
The First People's Hospital of Foshan
Foshan, China
RECRUITINGSun Yet-Sen University Cancer Center
Guangzhou, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
3-year overall survival
The proportion of patients alive at 3 years after entry into the study
Time frame: Participants will be followed for at least 3 years after randomization
Overall survival
Time from entry into the study to any cause of death
Time frame: Participants will be followed for at least 3 years after randomization
Progression-free survival
Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Time frame: Participants will be followed for at least 3 years after randomization
Post-operative complications
The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery
Time frame: Participants will be followed up to 3 months after randomization
Quality of life assessments
QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)
Time frame: Participants will be followed for at least 3 years after randomization
Accumulated treatment-free survival
Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy)
Time frame: Participants will be followed for at least 3 years or death after randomization
TFST
Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first
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For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China
Hefei, China
RECRUITINGFudan University Cancer Hospital
Shanghai, China
RECRUITINGObstetrics and Gynecology Hospital of Fundan University
Shanghai, China
RECRUITINGXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGTime frame: Participants will be followed for at least 3 years or death after randomization
TSST
Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first
Time frame: Participants will be followed for at least 3 years or death after randomization
The pattern of the first relapse
The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
Time frame: Participants will be followed for at least 3 years or death after randomization