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| Name | Class |
|---|---|
| Beijing Jishuitan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative moderately fractionated RT with Fluzoparib | Experimental | Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week). Wide resection surgery would be done around 6 -10 weeks post-RT. |
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| Preoperative moderately fractionated RT without Fluzoparib | Experimental | Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). No radio-sensitizing drugs was given. Wide resection surgery would be done around 6 -10 weeks post-RT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week). |
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| Measure | Description | Time Frame |
|---|---|---|
| Major wound complications | Number of Participants with Major wound complications 4 months post-surgery | 4-months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicities | acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT | pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT |
| Late toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ning-Ning Lu, Dr. | Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Beijing | Beijing Municipality | China | |||
| Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
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| Preoperative moderately fractionated radiotherapay | Radiation | Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). |
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late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
| 6 months, 9 months, 12 months, 18 months and 24 months after surgery |
| Quality of Life | EORTC QLQ-C30 questionnaire | 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 | 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 | 2 weeks after surgery |
| 2-year overall survival | Incidence of participants who were alive | 2 year since enrollment |
| 2-year local control | Incidence of participants who had no Local relapse | 2 year since enrollment |
| Beijing |
| Beijing Municipality |
| China |