Clinical ResponseCESOFB-00NCT03742063

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

An observational study of Clinical Response and Histopathological Response, run by Peking University People's Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Clinical Response, Histopathological Response, Prognosis
What is being tested?: first-line chemotherapy
Type of treatment: Injection or infusion
How many people: 190 participants
Where: 2 sitesChina
Study dates: 1 Jun 2017to 30 Oct 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

(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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100044

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Clinical Response, Histopathological Response, Prognosis
Being tested: first-line chemotherapy
Keywords: osteosarcoma, Ewing sarcoma, clinical evaluation, pathological evaluation, chemotherapy, targeted therapy
Medical subject headings: Osteosarcoma, Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03742063
Study group	Role	What they receive
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%. Receives: 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%. Receives: 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%. Receives: 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. Receives: Drug: first-line chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2-3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201730 Oct 2018

First posted15 Nov 2018
Study start1 Jun 2017
Primary completion31 Dec 2017
Study completion30 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Clinical ResponseStudies of the same condition, open and under way.
More trials run by Peking University People's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03742063
Sponsor's protocol ID: CBTRA-00
Acronym: CESOFB-00
Status last verified: Apr 2019
First submitted: 11 Nov 2018
Last updated: 10 Apr 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Moertel CG, Hanley JA. The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer. 1976 Jul;38(1):388-94. doi: 10.1002/1097-0142(197607)38:13.0.co;2-a.
PubMed 947531
Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
PubMed 19403881
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Choi H, Charnsangavej C, Faria SC, Macapinlac HA, Burgess MA, Patel SR, Chen LL, Podoloff DA, Benjamin RS. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol. 2007 May 1;25(13):1753-9. doi: 10.1200/JCO.2006.07.3049.
PubMed 17470865
Hamaoka T, Madewell JE, Podoloff DA, Hortobagyi GN, Ueno NT. Bone imaging in metastatic breast cancer. J Clin Oncol. 2004 Jul 15;22(14):2942-53. doi: 10.1200/JCO.2004.08.181.
PubMed 15254062
Smith AD, Shah SN, Rini BI, Lieber ML, Remer EM. Morphology, Attenuation, Size, and Structure (MASS) criteria: assessing response and predicting clinical outcome in metastatic renal cell carcinoma on antiangiogenic targeted therapy. AJR Am J Roentgenol. 2010 Jun;194(6):1470-8. doi: 10.2214/AJR.09.3456.
PubMed 20489085
Smith AD, Lieber ML, Shah SN. Assessing tumor response and detecting recurrence in metastatic renal cell carcinoma on targeted therapy: importance of size and attenuation on contrast-enhanced CT. AJR Am J Roentgenol. 2010 Jan;194(1):157-65. doi: 10.2214/AJR.09.2941.
PubMed 20028918
Tsuchida Y, Therasse P. Response evaluation criteria in solid tumors (RECIST): new guidelines. Med Pediatr Oncol. 2001 Jul;37(1):1-3. doi: 10.1002/mpo.1154. No abstract available.
PubMed 11466715
Costelloe CM, Chuang HH, Madewell JE, Ueno NT. Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST. J Cancer. 2010 Jun 28;1:80-92. doi: 10.7150/jca.1.80.
PubMed 20842228
Bajpai J, Kumar R, Sreenivas V, Sharma MC, Khan SA, Rastogi S, Malhotra A, Gamnagatti S, Kumar R, Safaya R, Bakhshi S. Prediction of chemotherapy response by PET-CT in osteosarcoma: correlation with histologic necrosis. J Pediatr Hematol Oncol. 2011 Oct;33(7):e271-8. doi: 10.1097/MPH.0b013e31820ff78e.
PubMed 22193290
Byun BH, Kim SH, Lim SM, Lim I, Kong CB, Song WS, Cho WH, Jeon DG, Lee SY, Koh JS, Chung SK. Prediction of response to neoadjuvant chemotherapy in osteosarcoma using dual-phase (18)F-FDG PET/CT. Eur Radiol. 2015 Jul;25(7):2015-24. doi: 10.1007/s00330-015-3609-3. Epub 2015 Feb 14.
PubMed 25680716
Bajpai J, Gamnagatti S, Kumar R, Sreenivas V, Sharma MC, Khan SA, Rastogi S, Malhotra A, Safaya R, Bakhshi S. Role of MRI in osteosarcoma for evaluation and prediction of chemotherapy response: correlation with histological necrosis. Pediatr Radiol. 2011 Apr;41(4):441-50. doi: 10.1007/s00247-010-1876-3. Epub 2010 Oct 27.
PubMed 20978754
Lamuraglia M, Raslan S, Elaidi R, Oudard S, Escudier B, Slimane K, Penna RR, Wagner M, Lucidarme O. mTOR-inhibitor treatment of metastatic renal cell carcinoma: contribution of Choi and modified Choi criteria assessed in 2D or 3D to evaluate tumor response. Eur Radiol. 2016 Jan;26(1):278-85. doi: 10.1007/s00330-015-3828-7. Epub 2015 May 8.
PubMed 25953002
O JH, Lodge MA, Wahl RL. Practical PERCIST: A Simplified Guide to PET Response Criteria in Solid Tumors 1.0. Radiology. 2016 Aug;280(2):576-84. doi: 10.1148/radiol.2016142043. Epub 2016 Feb 24.
PubMed 26909647
Rosen G, Caparros B, Huvos AG, Kosloff C, Nirenberg A, Cacavio A, Marcove RC, Lane JM, Mehta B, Urban C. Preoperative chemotherapy for osteogenic sarcoma: selection of postoperative adjuvant chemotherapy based on the response of the primary tumor to preoperative chemotherapy. Cancer. 1982 Mar 15;49(6):1221-30. doi: 10.1002/1097-0142(19820315)49:63.0.co;2-e.
PubMed 6174200

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03742063
Acronym / sponsor ID: CESOFB-00 / CBTRA-00
Conditions: Clinical Response, Histopathological Response, Prognosis
Keywords: osteosarcoma, Ewing sarcoma, clinical evaluation, pathological evaluation, chemotherapy, targeted therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Collaborators: Peking University Shougang Hospital
Study start: 1 Jun 2017 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 30 Oct 2018 (actual)
First posted: 15 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Huvos group I	–	Drug: first-line chemotherapyUpon 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%.
Huvos group II	–	Drug: first-line chemotherapyUpon 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%.
Huvos group III	–	Drug: first-line chemotherapyUpon 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%.
Huvos group IV	–	Drug: first-line chemotherapyUpon 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (5 listed)

(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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
first-line chemotherapypatients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)	Drug	Huvos group I, Huvos group II, Huvos group III, Huvos group IV

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Background: PubMed 947531Moertel CG, Hanley JA. The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer. 1976 Jul;38(1):388-94. doi: 10.1002/1097-0142(197607)38:13.0.co;2-a.
Background: PubMed 19403881Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Background: PubMed 17470865Choi H, Charnsangavej C, Faria SC, Macapinlac HA, Burgess MA, Patel SR, Chen LL, Podoloff DA, Benjamin RS. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol. 2007 May 1;25(13):1753-9. doi: 10.1200/JCO.2006.07.3049.
Background: PubMed 15254062Hamaoka T, Madewell JE, Podoloff DA, Hortobagyi GN, Ueno NT. Bone imaging in metastatic breast cancer. J Clin Oncol. 2004 Jul 15;22(14):2942-53. doi: 10.1200/JCO.2004.08.181.
Background: PubMed 20489085Smith AD, Shah SN, Rini BI, Lieber ML, Remer EM. Morphology, Attenuation, Size, and Structure (MASS) criteria: assessing response and predicting clinical outcome in metastatic renal cell carcinoma on antiangiogenic targeted therapy. AJR Am J Roentgenol. 2010 Jun;194(6):1470-8. doi: 10.2214/AJR.09.3456.
Background: PubMed 20028918Smith AD, Lieber ML, Shah SN. Assessing tumor response and detecting recurrence in metastatic renal cell carcinoma on targeted therapy: importance of size and attenuation on contrast-enhanced CT. AJR Am J Roentgenol. 2010 Jan;194(1):157-65. doi: 10.2214/AJR.09.2941.
Background: PubMed 11466715Tsuchida Y, Therasse P. Response evaluation criteria in solid tumors (RECIST): new guidelines. Med Pediatr Oncol. 2001 Jul;37(1):1-3. doi: 10.1002/mpo.1154. No abstract available.
Background: PubMed 20842228Costelloe CM, Chuang HH, Madewell JE, Ueno NT. Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST. J Cancer. 2010 Jun 28;1:80-92. doi: 10.7150/jca.1.80.
Background: PubMed 22193290Bajpai J, Kumar R, Sreenivas V, Sharma MC, Khan SA, Rastogi S, Malhotra A, Gamnagatti S, Kumar R, Safaya R, Bakhshi S. Prediction of chemotherapy response by PET-CT in osteosarcoma: correlation with histologic necrosis. J Pediatr Hematol Oncol. 2011 Oct;33(7):e271-8. doi: 10.1097/MPH.0b013e31820ff78e.
Background: PubMed 25680716Byun BH, Kim SH, Lim SM, Lim I, Kong CB, Song WS, Cho WH, Jeon DG, Lee SY, Koh JS, Chung SK. Prediction of response to neoadjuvant chemotherapy in osteosarcoma using dual-phase (18)F-FDG PET/CT. Eur Radiol. 2015 Jul;25(7):2015-24. doi: 10.1007/s00330-015-3609-3. Epub 2015 Feb 14.
Background: PubMed 20978754Bajpai J, Gamnagatti S, Kumar R, Sreenivas V, Sharma MC, Khan SA, Rastogi S, Malhotra A, Safaya R, Bakhshi S. Role of MRI in osteosarcoma for evaluation and prediction of chemotherapy response: correlation with histological necrosis. Pediatr Radiol. 2011 Apr;41(4):441-50. doi: 10.1007/s00247-010-1876-3. Epub 2010 Oct 27.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei Guo, Ph.D. and M.D. principal investigator

Musculoskeletal Tumor Center of Peking University People's Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Clinical Response and Histopathological Response, run by Peking University People's Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor necrosis rate (time frame: 2-3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742063, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.