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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00686738

Enrollment

Registered

2008-05-30

Start date

2007-02-28

Completion date

2015-12-31

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
histopathologic necrosis fractions of surgically removed tumor specimen	12-17 weeks after starting chemotherapy

Countries

South Korea

Outcome results