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Clinical Evaluation of Neoadjuvant Chemotherapy for Primary Malignant Sarcomas That Originate in Bone (CESOFB-00)

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ClinicalTrials.gov Identifier: NCT03742063
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Peking University Shougang Hospital
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
For bone lesions treated with chemotherapy or targeted therapy, particularly for sarcomas that originate in bones, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is spurious because bone lesions are typically located in irregularly shaped bones, are difficult to measure accurately, and usually respond more slowly to treatment than soft tissue lesions. Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) allows for response to be measured in the absence of anatomic changes through assessment of metabolic activity. It does not, however, account for morphologic changes. This study evaluated whether clinical imaging findings of sarcomas after preoperative chemotherapy correlate with tumor responses by pathological evaluation using the rate of necrosis to develop reliable and quantitative clinical response criteria.

Condition or disease Intervention/treatment
Clinical Response Histopathological Response Prognosis Drug: first-line chemotherapy

Detailed Description:
We reviewed a total of 190 primary lesions by clinical imaging, including X-ray, computed tomography (CT), magnetic resonance imaging, and bone scan or PET/CT in patients who received neoadjuvant chemotherapy. All patients had curative surgery of those lesions at Peking University People's Hospital or Peking University Shougang Hospital. Pathological evaluation was completed by determination of the tumor necrosis rate following Huvos' description. We also performed statistical diversity analysis for different pathological groups and generated receiver operating characteristic curves (ROC) to define the thresholds to distinguish different pathological groups.

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Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Evaluation of Neoadjuvant Chemotherapy for Primary Malignant Sarcomas That Originate in Bone: a Multi-center Retrospective Study for Standardization and Modification of Response Evaluation Criteria
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : October 30, 2018

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Group/Cohort Intervention/treatment
Huvos group I
Upon histopathological examination, the tumor response was assessed on the basis of the presence and extent of necrosis, which was assessed by a combination of gross and microscopic observations. Tumor necrosis was graded as per Picci et al. tumor histopathological response grading (Huvos classification), where grade I is 0% to 49%.
Drug: first-line chemotherapy
patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)

Huvos group II
Upon histopathological examination, the tumor response was assessed on the basis of the presence and extent of necrosis, which was assessed by a combination of gross and microscopic observations. Tumor necrosis was graded as per Picci et al. tumor histopathological response grading (Huvos classification), where grade II is 50% to 89%.
Drug: first-line chemotherapy
patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)

Huvos group III
Upon histopathological examination, the tumor response was assessed on the basis of the presence and extent of necrosis, which was assessed by a combination of gross and microscopic observations. Tumor necrosis was graded as per Picci et al. tumor histopathological response grading (Huvos classification), where grade III is 90% to 99%.
Drug: first-line chemotherapy
patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)

Huvos group IV
Upon histopathological examination, the tumor response was assessed on the basis of the presence and extent of necrosis, which was assessed by a combination of gross and microscopic observations. Tumor necrosis was graded as per Picci et al. tumor histopathological response grading (Huvos classification), where grade IV is 100% necrosis.
Drug: first-line chemotherapy
patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)




Primary Outcome Measures :
  1. Tumor necrosis rate [ Time Frame: 2-3 months ]
    We evaluated all surgical resection specimens and were blinded to the clinical status. Upon histopathological examination, the tumor response was assessed on the basis of the presence and extent of necrosis, which was assessed by a combination of gross and microscopic observations. Tumor necrosis was graded as per Picci et al. tumor histopathological response grading (Huvos classification), where grade I is 0% to 49%, grade II is 50% to 89%, grade III is 90% to 99%, and grade IV is 100% necrosis.



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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
We retrospectively reviewed medical records of 190 patients with high-grade sarcomas (mainly osteosarcomas and Ewing's sarcomas) that originated in bone, who received neoadjuvant chemotherapy from June 1, 2014, to March 1, 2017, at Peking University People's Hospital and Peking University Shougang Hospital.
Criteria

Inclusion Criteria:

  • (1) patients with high-grade sarcoma that originated in bone and confirmed histologically;
  • (2) patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES);
  • (3) patients who had primary tumor resection with assessment of histological response according to literatures;
  • (4) patients who had intact pre- and post-neoadjuvant chemotherapy imaging, which included X-ray, contrasted computed tomography (CT), and magnetic resonance imaging (MRI) of the primary lesions as well as chest CT (with each layer ≤5 mm), bone scan, or [18F]2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET);
  • (5) patients for whom follow-up information and evaluation after chemotherapy were available.

Exclusion Criteria:

  • patients with incomplete medical materials;
  • patients without surgery of the primary site/ without pathological analysis of the specimens;

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): NCT03742063


Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Peking University Shougang Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Peking University Shougang Hospital
Investigators
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Principal Investigator: Wei Guo, Ph.D. and M.D. Musculoskeletal Tumor Center of Peking University People's Hospital
Additional Information:

Publications:

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03742063    
Other Study ID Numbers: CBTRA-00
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
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:
osteosarcoma
Ewing sarcoma
clinical evaluation
pathological evaluation
chemotherapy
targeted therapy
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms