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

March 22, 2016 updated by: Byung-Kiu Park, National Cancer Center, Korea

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang-si, Gyeonggi, Korea, Republic of
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

osteosarcoma patients hospitalized to National Cancer Center, Korea

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Byung-Kiu Park, M.D., Ph.D., Pediatric Oncology Branch, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

May 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-07-256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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