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

Completed

• Conditions: Osteosarcoma

• Registration Number: NCT00686738
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Primary Completion: 2012-11
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi, Korea, Republic of