UMIN-CTR Clinical Trial

Public title

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

Acronym

A phase 2 study of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma

Scientific Title

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

Scientific Title:Acronym

A phase 2 study of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma

Region

Japan

Condition

intermediate risk neuroblastomas

Classification by specialty

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Objective of the study is to investigate efficacy and safety of the operation based on IDRF and chemotherapy for intermediate risk neuroblastoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

3 years progression-free survival rates

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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 carboplatin450mg/m2 on day 1). and were evaluated of possibility of surgical resection every three courses. When the effect is insufficient, it changes to stronger regemen(LI-D/E).

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

0

years-old

<=

Age-upper limit

18

years-old

>

Gender

Male and Female

Key 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

Key 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

Target sample size

73

Name of lead principal investigator

1st name
Middle name
Last name	Tomoko Iehara

Organization

Kyoto Prefectural University of Medicine

Division name

Pediatrics

Zip code

Address

Kawaramachi-Hirokoji Kamigyo-ku, Kyoto 602-8566

TEL

075-251-5571

Email

iehara@koto.kpu-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomoko Iehara

Organization

Kyoto Prefectural University of Medicine

Division name

Pediatrics

Zip code

Address

Kawaramachi-Hirokoji Kamigyo-ku, Kyoto 602-8566

TEL

075-251-5571

Homepage URL

http://www.jnbsg.jp

Email

iehara@koto.kpu-m.ac.jp

Institute

Japan Neuroblastoma Study Group

Institute

Department

Personal name

Organization

A research grant from the Ministry of Health,
Labor and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

12

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2010

Year

11

Month

10

Day

Date of IRB

Anticipated trial start date

2010

Year

12

Month

01

Day

Last follow-up date

2018

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

12

Month

09

Day

Last modified on

2014

Year

12

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005582