Skip to content

A phase 2 study of the decision of surgical adjustment time based on IDRF (Image Defined Risk Factors), and chemotherapy that gradually improve strength for intermediate risk neuroblastoma

A phase 2 study of the decision of surgical adjustment time based on IDRF (Image Defined Risk Factors), and chemotherapy that gradually improve strength for intermediate risk neuroblastoma - A phase 2 study of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004700
Enrollment
73
Registered
2010-12-09
Start date
2010-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermediate risk neuroblastomas

Interventions

Patients were given induction therapy LI-B (vincristine 1.5mg/m2 and cyclophosphamide 600mg/m2on day 1, pirarubicin 30mg/m2 on day 3) or LI-C (vincristine 1.5mg/m2, cyclophosphamide 900mg/m2 and carbo

Sponsors

Japan Neuroblastoma Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)age;day0-18 years old (2)diagnosis;histologically confirmed neuroblastoma or ganglioneuroblastoma by biopsy sample of primary tumor or metastatic tumor (include bone marrow). However, if the urine VMA and HVA (tumor marker) increase and MIBG scintigraphy are positivities, when the biopsy is difficult because of patient's condition, the patients can be diagnosed as the neuroblastoma. (3)staging and prognostic factors stage 3 (12months<= and Favorable Histology,12-18months and Unfavorable Histology) MYCN gene not amplification stage 4(12 months>, 12-18months and Favorable Histology and DNA index>1) MYCN gene not amplification stage 4S(Unfavorable Histology or Favorable Histology and DNA index=1) MYCN gene not amplification (4) no pre-emptive chemotherapy or radiotherapy (5) adequate major organ 1)Lansky performance status;30<= 2)Hemoatologic fanction;WBC>= 2000/mm3 3)Hepatic fanction;ALT 300 IU/l <= and t-bil 2.0 mg/dl>= 4)Renal fanction; 5 years old > 0.8 mg/dl>=, 5-10 years old 1.2 mg/dl>=, 10-18 years 1.5 mg/dl>=, 5)cardiac fanction; unnessesary treatment (6) written informed consent

Exclusion criteria

Exclusion criteria: (1)duplicate cancer (2)history of pregnancy or lactation (3) Patients complicated the mental disease or psychotic condition and were judged that can not participate in the study. (4) Patients whose participation in the study is judged to be inappropriate by the attending doctor

Design outcomes

Primary

MeasureTime frame
3 years progression-free survival rates

Countries

Japan

Contacts

Public ContactTomoko Iehara

Kyoto Prefectural University of Medicine Pediatrics

iehara@koto.kpu-m.ac.jp075-251-5571

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026