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Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05938374
Collaborator
Beijing Jishuitan Hospital (Other)
100
Enrollment
2
Locations
2
Arms
44
Anticipated Duration (Months)
50
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without FluzoparibPreoperative 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
Anticipated Primary Completion Date :
Apr 30, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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 Names:
  • RT+Fluzoparib

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major wound complications [4-months post-surgery]

      Number of Participants with Major wound complications 4 months post-surgery

    Secondary Outcome Measures

    1. Acute toxicities [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 [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 [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 [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 [2 weeks after surgery]

      No residual tumor cells were observed on post-operative specimens

    6. 2-year overall survival [2 year since enrollment]

      Incidence of participants who were alive

    7. 2-year local control [2 year since enrollment]

      Incidence of participants who had no Local relapse

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Jishuitan Hospital Beijing Beijing China
    2 Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center Beijing Beijing China

    Sponsors and Collaborators

    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Beijing Jishuitan Hospital

    Investigators

    • Principal Investigator: Ning-Ning Lu, Dr., Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 10, 2023
    Last Update Posted:
    Jul 10, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NINGNING LU, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    soft tissue sarcoma
    preoperative radiotherapy
    moderately fractionated RT
    Complications
    PARP inhibitor
    Additional relevant MeSH terms:
    Sarcoma
    Fluzoparib

    Study Results

    No Results Posted as of Jul 10, 2023