Grant-in-Aid for Scientific Research (A)
|Allocation Type||Single-year Grants |
|Research Institution||Keio University |
MORIKAWA Yasuhide Keio University, School of Medicine, Professor, 医学部, 教授 (90124958)
KUBOTA Tetsuro Keio University, School of Medicine, Associate Professor, 医学部, 助教授 (00118944)
HOSHINO Ken Keio University, School of Medicine, Assistant Professor, 医学部, 講師 (70190197)
OHTA Shigeru Shiga University of Medical Science, School of Medicine, Associate Professor, 医学部, 助教授 (40127014)
HARA Junichi Osaka University, School of Medicine, Associate Professor, 医学部, 助教授 (00238156)
HOSOI Hajime Kyoto Prefectural University of Medicine, School of Medicine, Assistant Professor, 医学部, 講師 (20238744)
|Project Period (FY)
2002 – 2004
Completed (Fiscal Year 2004)
|Budget Amount *help
¥31,590,000 (Direct Cost: ¥24,300,000、Indirect Cost: ¥7,290,000)
Fiscal Year 2004: ¥9,880,000 (Direct Cost: ¥7,600,000、Indirect Cost: ¥2,280,000)
Fiscal Year 2003: ¥8,710,000 (Direct Cost: ¥6,700,000、Indirect Cost: ¥2,010,000)
Fiscal Year 2002: ¥13,000,000 (Direct Cost: ¥10,000,000、Indirect Cost: ¥3,000,000)
|Keywords||Rhabdomyosarcoma / clinical trial / VAC / PAX3-FKHR / PAX7-FKHR / peripheral blood stem cell / VOD / children / 中央病理診断 / PAX3 / PAX7 / 胎児型 / 胞巣型 / グループスタディ / JRSG / リスク分類 / rhabdomyosarcoma / 小児がん / 放射線治療 / 外科治療|
The purpose of the present study is to prepare the new clinical trial for childhood rhabdomyosarcoma to improve poor outcome of the rhabdomyosarcoma in Japan.
1.The survey of the treatment of the rhabdomyosarcoma in Japan
1)331 cases treated during the period of 1991 to 2002 were assessed by the retrospective chart review. Overall 5 year survival revealed 60.7% that was 10-20% lower that IRS.
2)The follow up study of the previous trial for high-dose chemo. + stem cell transplantation did not provide any conclusion.
3)There is no consensus among pediatric surgeons for the surgical margin, timing of the radical operation and the range of lymph node resection.
2.Development of the new clinical trial for the rhabdomyosarcoma Based upon the survey described above, the new clinical trial was prepared in children.
1)The guideline for surgery and radiation was introduced based on the IRS.
2)The system for central review for pathology and the chimeric gene of PAX3,7-FKHR were developed.
3)Study protocol were prepared according to the risk classification. For Low A and B, dose of VAC and its treatment period were diminished. For intermediate group, VAC with dose adjustment for children was adopted. High dose chemo. and stem cell rescue was applied for high risk group. Primary endpoint of the study is determined as 3 year event free, no progression survival.
4)Data center was established in each study ; Kobe TRI center for Low Risk, JRSG central office for Intermediate Risk and National Cancer Center for High Risk protocol.
5)Tissue bank of the childhood tumor was developed for further basic study.
6)The clinical trial started in 2004 and 24 cases were entered. Among these, 14 cases were qualified to enrolle for clinical trial.