The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.
The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
356
Complete Cytoreduction
6 cycles of postoperative chemotherapy
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Overall survival
from date of randomisation until death
Time frame: Up to 60 months after last patient randomized
Progression-free survival
interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first
Time frame: Up to 24 months after last patient randomized
Accumulating Treatment-free survival (TFSa)
the time of OS minus each treatment period after randomization, including surgery and chemotherapy
Time frame: Up to 60 months after last patient randomized
Overall survival after the adjustment of one-way treatment switching
OS adjusted by statistical models for crossover
Time frame: Up to 60 months after last patient randomized
30-day post-operative complications
MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
Time frame: From the operation until after 30 days
Validation of iMODEL
iMODEL score to predict complete resection
Time frame: From randomization to operation
Patient compliance
compliance with protocol
Time frame: Up to 60 months after last patient randomized
Quality of life assessments
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The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)
Time frame: Study entry; 6 months; 12 months; 24 months and 60 months after randomization
Time to first subsequent anticancer therapy
From date of randomization until the date of first recurrent anticancer therapy
Time frame: Up to 60 months after last patient randomized
Time to second subsequent anticancer therapy
From date of randomization until the date of secondary recurrent anticancer therapy
Time frame: Up to 60 months after last patient randomized