Soft Tissue Sarcoma
Conditions
Keywords
soft tissue sarcoma, preoperative radiotherapy, moderately fractionated RT, Complications, PARP inhibitor
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.
Interventions
DRUGFluzoparib
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
RADIATIONPreoperative moderately fractionated radiotherapay
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
Sponsors
Beijing Jishuitan Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major wound complications | 4-months post-surgery | Number of Participants with Major wound complications 4 months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 overall survival | 2 year since enrollment | Incidence of participants who were alive |
| 2-year local control | 2 year since enrollment | Incidence of participants who had no Local relapse |
| Pathological complete remission rate | 2 weeks after surgery | No residual tumor cells were observed on post-operative specimens |
Countries
China
Outcome results
None listed