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

NCT00686738 | Completed DMC

• 1 other identifier: NCCCTS-07-256
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• histopathologic necrosis fractions of surgically removed tumor specimen

  12-17 weeks after starting chemotherapy

Study Arms (1)

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.

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

osteosarcoma patients hospitalized to National Cancer Center, Korea

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating women
• Cardiovascular dysfunction
• History of previous chemotherapy

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NF-kB expression status will be determined on initial biopsy and surgically removed tumor specimen.

MeSH Terms

Conditions

Osteosarcoma; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Byung-Kiu Park, M.D., Ph.D.

  Pediatric Oncology Branch, National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center for Pediatric Oncology

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: February 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

KR (1)