Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma

Conditions
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Soft Tissue Sarcoma

Intervention / Treatment
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* Drug: Fluzoparib
* Radiation: Preoperative moderately fractionated radiotherapay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 18 years. Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion. ECOG 0-3 Histology reviewed by reference pathologist Lesion can be assessed Can tolerate radiotherapy and Fluzoparib (Fluzoparib group) Agree contraception. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed Exclusion Criteria: No gross tumor post-resection in other center. Contraindications to Fluzoparib, including allergic to Fluzoparib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc. Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc. Benign histology Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma) STS can be cured by extensive operation alone. Previous irradiation to the same area radiological evidence of distant metastases Other contraindications, can't tolerate operation or other treatment needed in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative moderately fractionated RT with Fluzoparib<br>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. | Drug: Fluzoparib<br>* One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).<br>* Other names: RT+Fluzoparib;Radiation: Preoperative moderately fractionated radiotherapay<br>* Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).<br>* Other names: RT;|
| Experimental: Preoperative moderately fractionated RT without Fluzoparib<br>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. | Radiation: Preoperative moderately fractionated radiotherapay<br>* Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major wound complications | Number of Participants with Major wound complications 4 months post-surgery | 4-months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soft tissue sarcoma, preoperative radiotherapy, moderately fractionated RT, Complications, PARP inhibitor