Clinical Evaluation for Sarcoma Originated From Bone (CESOFB)

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.

Study Overview

• Status: Unknown
• Conditions: Survival; Sensitivity; Specificity; Histological Response

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Recruiting
    • Musculoskeletal Tumor Center of Peking University People's Hospital
  • Xi'an, China
    • Recruiting
    • Xijing Hospital
    • Contact: Zhen Wang, M.D.; Phone Number: +8613909298882; Email: wangzhen@fmmu.edu.cn
    • Sub-Investigator: Zhen Wang, M.D.
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affliated Hospital of Zhejiang University School of Medicine
      • Contact: Zhaoming Ye, M.D.; Phone Number: +8613606501549; Email: yezhaominghz@163.com
      • Contact: Zhaoming Ye, M.D.
      • Sub-Investigator: Zhaoming Ye, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.	12 months
Specificity	Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.	12 months
Pathological response rate	tumor necrosis rate descripted by Huvos	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	Progression-free survival is defined as time from diagnosis to the first occurrence of progression of disease or death from any cause	24 months
overall survival	overall survival is defined as time from diagnosis to death from any cause.	60 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Xijing Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Wei Guo, Musculoskeletal Tumor Center of Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): March 30, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 10, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: survival; osteosarcoma; Ewing sarcoma; RECIST; clinical evaluation; CESOFB; histological response
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: CBTRA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No