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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686738
• Other study ID #: NCCCTS-07-256
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: March 22, 2016
• Start date: February 2007
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 40 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteosarcoma

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histopathologic necrosis fractions of surgically removed tumor specimen		12-17 weeks after starting chemotherapy	No