Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686738
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : March 23, 2016
Information provided by (Responsible Party):
Byung-Kiu Park, National Cancer Center, Korea

Brief Summary:
The purpose of this study is to develop indices predicting response to pre-operative chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is very important for the ultimate outcome of osteosarcoma patients. Conventional methods such as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict chemotherapy response in osteosarcoma.

Condition or disease

Detailed Description:
We will conduct a prospective trial to verify the validity of indices utilizing TGF-b1, NF-kB, PET/CT, and MRS for predicting response to neoadjuvant chemotherapy in osteosarcoma patients. We assume that changes in plasma TGF-b1 levels, PET/CT and magnetic resonance spectroscopy (MRS) findings during the period of neoadjuvant chemotherapy as well as the initial nuclear NF-kB expression status of tumor biopsy specimen either alone or in combination may predict a chemotherapeutic response determined by histopathologic necrosis fractions of tumors removed. To test this, we will obtain TGF-b1 levels, PET/CT and MRS findings at diagnosis and at follow-up (after first and second/third chemotherapy cycle). Tumor will then be removed. Chemotherapy regimen comprised of various combination of cisplatin, adriamycin, and high-dose methotrexate, ifosfamide, and etoposide. Indices derived from TGF-b1, PET/CT, MRS predicting greater than 90% necrosis fractions will be sought utilizing statistical methods.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients
Study Start Date : February 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2015


Study group will be made up of patients hospitalized to National Cancer Center, Korea, aged between 5 and 40 years, and diagnosed with high grade osteosarcoma by histological exam.

In this group, TGF-b1 measurement, PET/CT and MRS examination at diagnosis, after 1st cycle chemotherapy, and 2nd or 3rd chemotherapy (just before surgery) will be made.

In addition, evaluation of NF-kB expression status in tumor specimens at diagnostic biopsy and tumor removing surgery will be done.

The results of above studies will be correlated with the necrosis fractions of the tumor tissues removed by surgery.

Primary Outcome Measures :
  1. histopathologic necrosis fractions of surgically removed tumor specimen [ Time Frame: 12-17 weeks after starting chemotherapy ]

Biospecimen Retention:   Samples Without DNA
NF-kB expression status will be determined on initial biopsy and surgically removed tumor specimen.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
osteosarcoma patients hospitalized to National Cancer Center, Korea

Inclusion Criteria:

  • Karnofsky (over 15 years) or Lansky (less than 15 years) score equal or greater than 50
  • Adequate organ functions:

    • GFR>60ml/min/1.73m2
    • EF>50% or SF>28% on echocardiogram
    • ANC>1.5 x 10^9/L
    • platelet>100 x 10^9/L
  • Obtainment of informed consents from parents/legal guardians and/or patients

Exclusion Criteria:

  • Pregnant or lactating women
  • Cardiovascular dysfunction
  • History of previous chemotherapy

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 identifier (NCT number): NCT00686738

Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Byung-Kiu Park, M.D., Ph.D. Pediatric Oncology Branch, National Cancer Center, Korea

Responsible Party: Byung-Kiu Park, Head of Center for Pediatric Oncology, National Cancer Center, Korea Identifier: NCT00686738     History of Changes
Other Study ID Numbers: NCCCTS-07-256
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Byung-Kiu Park, National Cancer Center, Korea:
transforming growth factor-beta 1
nuclear factor-kappa B
positron emission tomography/computed tomography
magnetic resonance spectroscopy
predicting response to neoadjuvant chemotherapy

Additional relevant MeSH terms:
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type