Clinical Evaluation of Neoadjuvant Chemotherapy for Primary Malignant Sarcomas That Originate in Bone

NCT03742063 | Completed DMC

• 1 other identifier: CBTRA-00
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 2

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.

Conditions

Clinical Response; Histopathological Response; Prognosis

Keywords

osteosarcoma; Ewing sarcoma; clinical evaluation; pathological evaluation; chemotherapy; targeted therapy

Outcome Measures

Primary Outcomes (1)

• Tumor necrosis rate

  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.

  2-3 months

Study Arms (4)

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

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

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

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

Interventions

first-line chemotherapy DRUG

patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)

Huvos group I; Huvos group II; Huvos group III; Huvos group IV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University Shougang Hospital: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (15)

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MeSH Terms

Conditions

Osteosarcoma; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Wei Guo, Ph.D. and M.D.

  Musculoskeletal Tumor Center of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 15, 2018
• Study Start: June 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: October 30, 2018
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CN (2)