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Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05938374
Recruitment Status : Recruiting
First Posted : July 10, 2023
Last Update Posted : July 10, 2023
Sponsor:
Collaborator:
Beijing Jishuitan Hospital
Information provided by (Responsible Party):
NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Fluzoparib Radiation: Preoperative moderately fractionated radiotherapay Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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).
Other Name: RT+Fluzoparib

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

Experimental: 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.

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




Primary Outcome Measures :
  1. Major wound complications [ Time Frame: 4-months post-surgery ]
    Number of Participants with Major wound complications 4 months post-surgery


Secondary Outcome Measures :
  1. Acute toxicities [ Time Frame: 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. Late toxicities [ Time Frame: 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

  3. Quality of Life [ Time Frame: 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

  4. Extremity function [ Time Frame: 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

  5. Pathological complete remission rate [ Time Frame: 2 weeks after surgery ]
    No residual tumor cells were observed on post-operative specimens

  6. 2-year overall survival [ Time Frame: 2 year since enrollment ]
    Incidence of participants who were alive

  7. 2-year local control [ Time Frame: 2 year since enrollment ]
    Incidence of participants who had no Local relapse



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05938374


Contacts
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Contact: Ning-Ning Lu, Dr. 0118613051396569 Ning-Ning.Lu@hotmail.com
Contact: Lu-Qiang Wang, Dr. wangluqiang_lm@163.com

Locations
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China, Beijing
Beijing Jishuitan Hospital Recruiting
Beijing, Beijing, China
Contact: Tao Jin, Dr.         
Contact: Zhuo-Yu Li         
Principal Investigator: Wei-Feng Liu, Dr.         
Sub-Investigator: Qing Zhang, Dr.         
Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center Recruiting
Beijing, Beijing, China
Contact: Ning-Ning Lu, Dr.    0118613051396569    Ning-Ning.Lu@hotmail.com   
Contact: Lu-Qiang Wang, Dr.       wangluqiang_lm@163.com   
Principal Investigator: Ning-Ning Lu, Dr.         
Principal Investigator: Sheng-Ji Yu, Dr.         
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Jishuitan Hospital
Investigators
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Principal Investigator: Ning-Ning Lu, Dr. Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China
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Responsible Party: NINGNING LU, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT05938374    
Other Study ID Numbers: NCC-4016
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: July 10, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
soft tissue sarcoma
preoperative radiotherapy
moderately fractionated RT
Complications
PARP inhibitor
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Fluzoparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents