The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?
OBJECTIVES: Compare the efficacy and safety in patients with AJCC TNM stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery. OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy. Patients are followed every 3 months within the first 5 years, and then every 6 months. PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study within 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
489
Upfront cytoreductive 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
Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Overall survival
The time from entry into the study to any cause of death.
Time frame: Participants will be followed for at least 5 years after randomization or until death
Progression-free survival
The 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 5 years after randomization or until death
Post-operative complications
The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery.
Time frame: Participants will be followed up to 6 months after randomization
Quality of life assessments
QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization)
Time frame: Participants will be followed for at least 5 years after randomization or until death
Accumulated treatment-free survival (TFSa)
The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment.
Time frame: Participants will be followed for at least 5 years after randomization or until death
Time to first subsequent anticancer therapy (TFST)
The date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines.
Time frame: Participants will be followed for at least 5 years after randomization or until death
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Hunan Provincial Hospital
Changsha, China
Seoul National University Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Time to second subsequent anticancer therapy (TSST)
The date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines.
Time frame: Participants will be followed for at least 5 years after randomization or until death
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 5 years after randomization or until death
The rate of 5-year progression-free survival
The rate of the patients without progression or recurrence or death at 5 years.
Time frame: Participants will be followed for at least 5 years after randomization or until death
Outcomes of pulmonary embolism
The incidence of pulmonary embolism prior to primary treatment in the ITT and hospital populations. Its effect on survival between groups in the ITT and hospital populations.
Time frame: Participants will be followed for at least 5 years after randomization or until death