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Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients


N/A
5 Years
40 Years
Open (Enrolling)
Both
Osteosarcoma

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Trial Information

Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

histopathologic necrosis fractions of surgically removed tumor specimen

Outcome Time Frame:

12-17 weeks after starting chemotherapy

Safety Issue:

No

Principal Investigator

Byung-Kiu Park, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pediatric Oncology Branch, National Cancer Center, Korea

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

NCCCTS-07-256

NCT ID:

NCT00686738

Start Date:

February 2007

Completion Date:

December 2012

Related Keywords:

  • Osteosarcoma
  • osteosarcoma
  • transforming growth factor-beta 1
  • nuclear factor-kappa B
  • positron emission tomography/computed tomography
  • magnetic resonance spectroscopy
  • predicting response to neoadjuvant chemotherapy
  • Osteosarcoma

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