Fluzoparib
DrugOne week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Other names: RT+Fluzoparib
NCT Number: NCT05938374
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Beijing Jishuitan Hospital, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Other names: RT+Fluzoparib
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
Other names: RT
Time frame: 4-months post-surgery
Number of Participants with Major wound complications 4 months post-surgery
Time frame: pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT
Time frame: 6 months, 9 months, 12 months, 18 months and 24 months after surgery
late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
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
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
MSTS questionnaire, TESS questionnaire
Time frame: 2 weeks after surgery
No residual tumor cells were observed on post-operative specimens
Time frame: 2 year since enrollment
Incidence of participants who were alive
Time frame: 2 year since enrollment
Incidence of participants who had no Local relapse
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
Acronym: SPARE-03
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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