Development of Indices Predicting Response to Pre-operative 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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients|
- histopathologic necrosis fractions of surgically removed tumor specimen [ Time Frame: 12-17 weeks after starting chemotherapy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
NF-kB expression status will be determined on initial biopsy and surgically removed tumor specimen.
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686738
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi, Korea, Republic of|
|Principal Investigator:||Byung-Kiu Park, M.D., Ph.D.||Pediatric Oncology Branch, National Cancer Center, Korea|