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Trial Title:
Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma
NCT ID:
NCT05938374
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Fluzoparib
Conditions: Keywords:
soft tissue sarcoma
preoperative radiotherapy
moderately fractionated RT
Complications
PARP inhibitor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately
fractionated RT without Fluzoparib
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take
oral Fluzoparib (100mg, BID, five days per week).
Arm group label:
Preoperative moderately fractionated RT with Fluzoparib
Other name:
RT+Fluzoparib
Intervention type:
Radiation
Intervention name:
Preoperative moderately fractionated radiotherapay
Description:
Patients will receive preoperative moderately fractionated radiotherapy
(RT)(43.5Gy/15fr).
Arm group label:
Preoperative moderately fractionated RT with Fluzoparib
Arm group label:
Preoperative moderately fractionated RT without Fluzoparib
Other name:
RT
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Jishuitan Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Jin, Dr.
Contact backup:
Last name:
Zhuo-Yu Li
Investigator:
Last name:
Wei-Feng Liu, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Qing Zhang, Dr.
Email:
Sub-Investigator
Facility:
Name:
Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning-Ning Lu, Dr.
Phone:
0118613051396569
Email:
Ning-Ning.Lu@hotmail.com
Contact backup:
Last name:
Lu-Qiang Wang, Dr.
Email:
wangluqiang_lm@163.com
Investigator:
Last name:
Ning-Ning Lu, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Sheng-Ji Yu, Dr.
Email:
Principal Investigator
Start date:
May 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Beijing Jishuitan Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05938374
