Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Radiation: Preoperative moderately fractionated radiotherapay
- Registration Number
- NCT05938374
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated radiotherapay 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. Preoperative moderately fractionated RT without Fluzoparib Preoperative moderately fractionated radiotherapay 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. Preoperative moderately fractionated RT with Fluzoparib Fluzoparib 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.
- Primary Outcome Measures
Name Time Method Major wound complications 4-months post-surgery Number of Participants with Major wound complications 4 months post-surgery
- Secondary Outcome Measures
Name Time Method Pathological complete remission rate 2 weeks after surgery No residual tumor cells were observed on post-operative specimens
Late toxicities 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
Quality of Life 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
Extremity function 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
2-year overall survival 2 year since enrollment Incidence of participants who were alive
Acute toxicities 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
2-year local control 2 year since enrollment Incidence of participants who had no Local relapse
Trial Locations
- Locations (2)
Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
🇨🇳Beijing, Beijing, China
Beijing Jishuitan Hospital
🇨🇳Beijing, Beijing, China