Clinical Evaluation for Sarcoma Originated From Bone

Survival Clinical Trial

— CESOFB  

Official title:

Clinical Evaluation for Sarcoma Originated From Bone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03358992
• Other study ID #: CBTRA-01
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: November 2018
• Source: Peking University People's Hospital
• Contact: Lu Xie, M.D.
• Phone: +86-13401044719
• Email: sweetdoctor[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Histological Response
• Sarcoma
• Sensitivity
• Specificity
• Survival

Locations

Country	Name	City	State
China	Musculoskeletal Tumor Center of Peking University People's Hospital	Beijing
China	The second affliated Hospital of Zhejiang University School of medicine	Hangzhou	Zhejiang
China	Xijing Hospital	Xi'an

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Second Affiliated Hospital, School of Medicine, Zhejiang University, Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.	12 months
Primary	Specificity	Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.	12 months
Primary	Pathological response rate	tumor necrosis rate descripted by Huvos	12 months
Secondary	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
Secondary	overall survival	overall survival is defined as time from diagnosis to death from any cause.	60 months