CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 190 enrolled
Drug / intervention
first-line chemotherapydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03742063
NCT03742063N/ACompleted

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

Peking University People's Hospital·observational·Posted Nov 15, 2018·Updated Apr 10, 2019

In Brief

An observational study evaluating first-line chemotherapy for Clinical Response and 2 related conditions. Completed, enrolled 190 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 15, 2018
Enrollment StartJun 1, 2017
Primary CompletionDec 31, 2017
Study CompletionOct 30, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.6 years ago

Interventions

first-line chemotherapydrug

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