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

This study is currently recruiting participants.
Verified January 2012 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Byung-Kiu Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00686738
First received: May 27, 2008
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Osteosarcoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • histopathologic necrosis fractions of surgically removed tumor specimen [ Time Frame: 12-17 weeks after starting chemotherapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

NF-kB expression status will be determined on initial biopsy and surgically removed tumor specimen.


Estimated Enrollment: 20
Study Start Date: February 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
A

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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

osteosarcoma patients hospitalized to National Cancer Center, Korea

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686738

Contacts
Contact: Mimi Kwon, RN 82-31-920--0941 rnjsalal1004@nate.com

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Soon Mi Kim, RN     82-31-920-0425     ksm@ncc.re.kr    
Principal Investigator: Byung-Kiu Park, M.D., Ph.D.            
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Byung-Kiu Park, M.D., Ph.D. Pediatric Oncology Branch, National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Byung-Kiu Park, Head of Center for Pediatric Oncology, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00686738     History of Changes
Other Study ID Numbers: NCCCTS-07-256
Study First Received: May 27, 2008
Last Updated: January 23, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
osteosarcoma
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:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on May 22, 2013