Clinical trial NCT03358992: Clinical Evaluation for Sarcoma Originated From Bone
Official title: Clinical Evaluation for Sarcoma Originated From Bone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensitivity
Specificity
Histological Response
Survival
Keywords: CESOFB
clinical evaluation
RECIST
histological response
survival
osteosarcoma
Ewing sarcoma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Xijing Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2017-12-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity
timeFrame: 12 months
measure: Specificity
timeFrame: 12 months
measure: Pathological response rate
timeFrame: 12 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 24 months
measure: overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affliated Hospital of Zhejiang University School of medicine
state: Zhejiang
city: Beijing
country: China
facility: Musculoskeletal Tumor Center of Peking University People's Hospital
city: Xi'an
country: China
facility: Xijing Hospital
Study officials:
affiliation: Musculoskeletal Tumor Center of Peking University People's Hospital
name: Wei Guo
role: PRINCIPAL_INVESTIGATOR
References: