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Clinical Evaluation for Sarcoma Originated From Bone (CESOFB)

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ClinicalTrials.gov Identifier: NCT03358992
Recruitment Status : Unknown
Verified November 2018 by Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Xijing Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Information provided by (Responsible Party):
Peking University People's Hospital

Study Description
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Brief Summary:
Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. This study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by Huvos classifications and develops reliable, quantitative, clinical response criteria.

Condition or disease
Sensitivity Specificity Histological Response Survival

Detailed Description:
A total of 1570 lesions were evaluated by clinical imaging including X-ray, computed tomography, magnetic resonance imaging and bone scan or PET/CT preoperatively treated with chemotherapy. All patients had surgery in our center and get pathological evaluation by tumor necrosis rate. Statistical diversity analysis was performed by different pathological groups and Receiver Operating Characteristic Curves，ROC were done to find the dividing clinical parameters (Cut-off values) to distinguish different pathological groups.The cut-off values of change rate of maximum diameters of tumor located in extremities were 86%, 50.7% and 0.02% for Huvos Ⅳ,Ⅲ,ⅡandⅠgroups. The differentiation was not obvious using bone scan to distinguish different pathological responses. And the cut-off value for SUVmax value for Huvos Ⅲ,ⅡandⅠgroups were 60.7% and 31.4%.After Multidisciplinary discussion in multiple sites of China, we finally designed a evaluation system based on our data. This study is desgined to prospectively compare the sensitivity and specificity of this Clinical evaluation of primary sarcoma originated from bone with other clinical evaluation system,such as RECIST 1.1, Choi and PERCIST.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation for Sarcoma Originated From Bone
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 12 months ]
    Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.

  2. Specificity [ Time Frame: 12 months ]
    Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.

  3. Pathological response rate [ Time Frame: 12 months ]
    tumor necrosis rate descripted by Huvos


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 24 months ]
    Progression-free survival is defined as time from diagnosis to the first occurrence of progression of disease or death from any cause

  2. overall survival [ Time Frame: 60 months ]
    overall survival is defined as time from diagnosis to death from any cause.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.
Criteria

Inclusion Criteria:

  • 1) histologically confirmed high-grade osteosarcoma;
  • 2) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital, Xijing Hospital or The Second Hospital affiliated to Zhejiang Hospital;
  • 3) imaging evaluation should be available;
  • 4) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
  • 5) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
  • 6) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

  • 1) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
  • 2) lost to follow-up.
Contacts and Locations
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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): NCT03358992


Contacts
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Contact: Lu Xie, M.D. +86-13401044719 sweetdoctor@163.com
Contact: Jie Xu, M.D. +86-15901040835 xujie_pkuph@sina.com

Locations
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China, Zhejiang
The second affliated Hospital of Zhejiang University School of medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Zhaoming Ye, M.D.    +8613606501549    yezhaominghz@163.com   
Contact: Zhaoming Ye, M.D.         
Sub-Investigator: Zhaoming Ye, M.D.         
China
Musculoskeletal Tumor Center of Peking University People's Hospital Recruiting
Beijing, China, 100044
Contact: Tingting Ren, Ph.D.    +86-13810095026    tumorcenter@163.com   
Xijing Hospital Recruiting
Xi'an, China
Contact: Zhen Wang, M.D.    +8613909298882    wangzhen@fmmu.edu.cn   
Sub-Investigator: Zhen Wang, M.D.         
Sponsors and Collaborators
Peking University People's Hospital
Xijing Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Wei Guo Musculoskeletal Tumor Center of Peking University People's Hospital
More Information
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03358992    
Other Study ID Numbers: CBTRA-01
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
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 Peking University People's Hospital:
CESOFB
clinical evaluation
RECIST
histological response
 survival
osteosarcoma
Ewing sarcoma
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms