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The development of the new clinical trial based on the quality assurance of treatment process in the childhood rhabdomyosarcoma.

Research Project

Project/Area Number 14207071
Research Category

Grant-in-Aid for Scientific Research (A)

Allocation TypeSingle-year Grants
Section一般
Research Field Pediatric surgery
Research InstitutionKeio University

Principal Investigator

MORIKAWA Yasuhide  Keio University, School of Medicine, Professor, 医学部, 教授 (90124958)

Co-Investigator(Kenkyū-buntansha) 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
Project Status 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)
KeywordsRhabdomyosarcoma / 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
Research Abstract

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.

Report

(4 results)
  • 2004 Annual Research Report   Final Research Report Summary
  • 2003 Annual Research Report
  • 2002 Annual Research Report
  • Research Products

    (28 results)

All 2004 2003 Other

All Journal Article (16 results) Publications (12 results)

  • [Journal Article] Multiple polypoid masses in the gastrointestinal tract in patient with Menkes disease on copper-histidinate therapy.2004

    • Author(s)
      Sasaki G, Ishii T, Morikawa Y et al.
    • Journal Title

      Eur J Pediatr 163(12)

      Pages: 745-746

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] LRRC8 involved in B cell development belongs to a novel family of leucine-rich repeat proteins.2004

    • Author(s)
      Kubota K, Hara J et al.
    • Journal Title

      FEBS Lett. 23;564(1-2)

      Pages: 147-152

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Multiple polypoid masses in the gastrointestinal tract in patient with Menkes disease on copper-histidinate therapy.2004

    • Author(s)
      Sasaki G, Ishii T, Morikawa Y et al.
    • Journal Title

      Eur J Pediatr. 163(12)

      Pages: 745-746

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] LRRC8 involved in B cell development belongs to a novel family of leucine-rich repeat proteins.2004

    • Author(s)
      Kubota K, Kara J et al.
    • Journal Title

      FEBS Lett. 23;564(1-2)

      Pages: 147-152

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Multiple polypoid masses in the gastrointestinal tract in patient with Menkes disease on copper-histidinate thearpy2004

    • Author(s)
      Sasaki G, Ishii T, Moriokawa Y et al.
    • Journal Title

      Eur J Pediatr 163(12)

      Pages: 745-746

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Cyclooxigenase-2 gene induction causes CDDP resistance in colon cancer cell line, HCT-152004

    • Author(s)
      Saikawa Y, Kubota T et al.
    • Journal Title

      Anticancer Res 21(3)

      Pages: 2723-2728

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Antitumor activity of gefitinib in malignant rhabdoid tumor cells in vitro and in vivo2004

    • Author(s)
      Kuwahara Y, Hosoi H, Osone S et al.
    • Journal Title

      Clin Cancer Res 10(17)

      Pages: 5940-5948

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Fenretinide induces sustained-activation of JNK/p38 MAPK and apoptosis ina reactive oxygen species-dependent manner in nueroblastoma cells.2004

    • Author(s)
      Osono S, Hosoi H, Kuwahara Y et al.
    • Journal Title

      Int J Cancer 112(2)

      Pages: 219-224

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Hepatocyte growth factor plays roles in the induction and autocrine maintenance of bone marrow stromal cell IL-11, SDF-1 alpha and stem cell factor.2004

    • Author(s)
      Matsuda-Hashii Y, Takai K, Hara J et al.
    • Journal Title

      Exp Hematol 32(10)

      Pages: 955-961

    • Related Report
      2004 Annual Research Report
  • [Journal Article] 横紋筋肉腫に対する治療プロトコール 化学療法レジメンと放射線治療および外科治療ガイドライン2004

    • Author(s)
      森川康英, 土田嘉昭, 原純一, 太田茂, 細井創, 池田均 ほか
    • Journal Title

      小児外科 36(7)

      Pages: 939-946

    • Related Report
      2004 Annual Research Report
  • [Journal Article] No incidence of port-site recurrence after endosurgical procedure for pediatric malignancies.2003

    • Author(s)
      Iwanaga T, Morikawa Y et al.
    • Journal Title

      Pediatr Surg Int. 19(3)

      Pages: 200-203

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] 5-Fluorouracil and dihydropyrimidine dehydrogenase.2003

    • Author(s)
      Kubota, T.
    • Journal Title

      International Journal of Clinical Oncology 8

      Pages: 127-131

    • NAID

      10014440429

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Expression of pericyte, mesangium and muscle markers in malignant rhabdoid tumor cell lines : Differentiation-induction using 5-azacytidine.2003

    • Author(s)
      Kato H, Ohta S et al.
    • Journal Title

      Cancer Sci 94(12)

      Pages: 1059-1065

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Regression of refractory rhabdomyosarcoma after allogeneic stem-cell transplantation.2003

    • Author(s)
      Misawa A, Hosoi H et al.
    • Journal Title

      Pediatr Hematol Oncol. 20(2)

      Pages: 151-155

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] No incidence of port-site recurrence after endosurgical procedure for pediatric malignancies.2003

    • Author(s)
      Iwanaka T, Morikawa Y et al.
    • Journal Title

      Pediatr Surg Int. 19(3)

      Pages: 200-203

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Expression of pericyte, mesangium and muscle markers in malignant rhabdoid tumor cell lines : Differentiation-induction using 5-azacytidine.2003

    • Author(s)
      Kato H.Ohta S et al.
    • Journal Title

      Cancer Sci. 94(12)

      Pages: 1059-1065

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Publications] 森川康英: "横紋筋肉腫の疫学"小児外科. 35・1. 8-12 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] 細井 創: "諸外国における横紋筋肉腫治療の現況"小児外科. 35・1. 13-20 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] 原 純一: "小児横紋筋肉腫に対する自家造血幹細胞救援併用大量化学療法の展望"小児外科. 35・1. 79-86 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] 太田 茂: "血液・腫瘍性疾患 性腺腫瘍"小児外科. 35巻増刊. 1276-1281 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] 池田 均: "低出生体重児の肝芽腫とその発生機序 酸素暴露と肝細胞のDNA障害"小児外科. 35・5. 556-561 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] Misawa A, Hosoi H, Tsuchiya K et al.: "Regression of refractory rhabdomyosarcoma after allogenic stem-cell transplantation"Pediatric Hematol Oncol. 20・2. 151-155 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] 森川康英: "横紋筋肉腫の疫学"小児外科. 35:1. 8-12 (2003)

    • Related Report
      2002 Annual Research Report
  • [Publications] 太田 茂: "横紋筋肉腫の分子生物学"小児外科. 35:1. 21-24 (2003)

    • Related Report
      2002 Annual Research Report
  • [Publications] 細井 創: "諸外国における横紋筋肉腫治療の現況-とくにIRSグループスタディの運営組織と"小児外科. 35:1. 13-20 (2003)

    • Related Report
      2002 Annual Research Report
  • [Publications] Kubota, T. et al.: "Different pathways of 5-fluorouracil metabolism after continuous venous or bolus injection in patients with colon carcinoma"Anticancer Research. 22. 891-893 (2002)

    • Related Report
      2002 Annual Research Report
  • [Publications] 原 純一: "白血病の分類immunosubtype"小児科診療. 65. 189-193 (2002)

    • Related Report
      2002 Annual Research Report
  • [Publications] 原 純一: "小児横紋筋肉腫に対する自家造血幹細胞救援併用大量化学療法の展望"小児外科. 35:1. 79-86 (2003)

    • Related Report
      2002 Annual Research Report

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Published: 2002-04-01   Modified: 2016-04-21  

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