Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Major wound complications
研究概览
简要总结
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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.
研究组 & 干预措施
Preoperative moderately fractionated RT with 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.
干预措施: Fluzoparib (Drug)
Preoperative moderately fractionated RT with 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.
干预措施: Preoperative moderately fractionated radiotherapay (Radiation)
Preoperative moderately fractionated RT without Fluzoparib
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.
干预措施: Preoperative moderately fractionated radiotherapay (Radiation)
结局指标
主要结局
Major wound complications
时间窗: 4-months post-surgery
Number of Participants with Major wound complications 4 months post-surgery
次要结局
- Pathological complete remission rate(2 weeks after surgery)
- 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)
- Late toxicities(6 months, 9 months, 12 months, 18 months and 24 months after surgery)
- 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)
- 2-year overall survival(2 year since enrollment)
- Acute toxicities(pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT)
- 2-year local control(2 year since enrollment)
研究者
NINGNING LU
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences