To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
Beijing, Beijing Municipality, China
Major wound complications
Number of Participants with Major wound complications 4 months post-surgery
Time frame: 4-months post-surgery
Acute toxicities
acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT
Time frame: pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
Late toxicities
late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
Time frame: 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Quality of Life
EORTC QLQ-C30 questionnaire
Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Extremity function
MSTS questionnaire, TESS questionnaire
Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Pathological complete remission rate
No residual tumor cells were observed on post-operative specimens
Time frame: 2 weeks after surgery
2-year overall survival
Incidence of participants who were alive
Time frame: 2 year since enrollment
2-year local control
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Incidence of participants who had no Local relapse
Time frame: 2 year since enrollment