Clinical trial NCT05938374: Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma
Official title: Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: soft tissue sarcoma
preoperative radiotherapy
moderately fractionated RT
Complications
PARP inhibitor
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
First posted: 2023-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Major wound complications
timeFrame: 4-months post-surgery
Secondary outcomes:
measure: Acute toxicities
timeFrame: pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
measure: Late toxicities
timeFrame: 6 months, 9 months, 12 months, 18 months and 24 months after surgery
measure: Quality of Life
timeFrame: 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
measure: Extremity function
timeFrame: 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
measure: Pathological complete remission rate
timeFrame: 2 weeks after surgery
measure: 2-year overall survival
timeFrame: 2 year since enrollment
measure: 2-year local control
timeFrame: 2 year since enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
state: Beijing
Study officials:
affiliation: Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China
name: Ning-Ning Lu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: