Clinical trial NCT00686738: Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients
Official title: Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2008-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: osteosarcoma patients hospitalized to 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.

Eligibility criteria: 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

Primary outcomes:
measure: histopathologic necrosis fractions of surgically removed tumor specimen
timeFrame: 12-17 weeks after starting chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: Pediatric Oncology Branch, National Cancer Center, Korea
name: Byung-Kiu Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: