Immune System Diseases

All Conditions

Neoplasms

Rare Diseases

Hypersensitivity

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Ewing Sarcoma

Lu Xie, M.D.

Jie Xu, M.D.

Zhaoming Ye, M.D.

Tingting Ren, Ph.D.

Zhen Wang, M.D.

Wei Guo

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.

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.

Clinical Evaluation for Sarcoma Originated From Bone

Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.

Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.

Progression-free survival is defined as time from diagnosis to the first occurrence of progression of disease or death from any cause

overall survival is defined as time from diagnosis to death from any cause.

Xijing Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Peking University People's Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Docetaxel

Cyclophosphamide

Epirubicin

FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE

TAXOTERE 100 mg/m²/cycle

1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100

Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy

Blood sampling

Biopsy at the moment of inclusion, before neoadjuvant chemotherapy

BIOPSY

SURGERY

BONNETERRE Jacques, MD, PhD

The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Evaluation for Sarcoma Originated From Bone	NCT03358992	Sensitivity Specificity Histological Re... Survival		-	Peking University People's Hospital
Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy	NCT00911911	Breast Cancer	Blood sampling BIOPSY SURGERY	18 Years -	Centre Oscar Lambret
Clinical Evaluation for Sarcoma Originated From Bone	NCT03358992	Sensitivity Specificity Histological Re... Survival		-	Peking University People's Hospital

Spots Global Cancer Trial Database for histological response