Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:

Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938374
• Other study ID #: NCC-4016
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Ning-Ning Lu, Dr.
• Phone: 0118613051396569
• Email: Ning-Ning.Lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Fluzoparib
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).

Radiation:
• Preoperative moderately fractionated radiotherapay
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major wound complications	Number of Participants with Major wound complications 4 months post-surgery	4-months post-surgery
Secondary	Acute toxicities	acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT	pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
Secondary	Late toxicities	late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months	6 months, 9 months, 12 months, 18 months and 24 months after surgery
Secondary	Quality of Life	EORTC QLQ-C30 questionnaire	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
Secondary	Extremity function	MSTS questionnaire, TESS questionnaire	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
Secondary	Pathological complete remission rate	No residual tumor cells were observed on post-operative specimens	2 weeks after surgery
Secondary	2-year overall survival	Incidence of participants who were alive	2 year since enrollment
Secondary	2-year local control	Incidence of participants who had no Local relapse	2 year since enrollment