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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003002
Receipt No. R000003638
Scientific Title Randomized phase II study of two cross-over sequences comprising outpatient chemotherapies, vinorelbine/cyclophosphamide (R1) and temozolomide/etoposide (R2), for relapsed or refractory solid tumors in children and young adults
Date of disclosure of the study information 2010/01/09
Last modified on 2015/01/09

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Basic information
Public title Randomized phase II study of two cross-over sequences comprising outpatient chemotherapies, vinorelbine/cyclophosphamide (R1) and temozolomide/etoposide (R2), for relapsed or refractory solid tumors in children and young adults
Acronym Cross-over rPII of outpatient chemotherapies for refractory pediatric solid tumors
Scientific Title Randomized phase II study of two cross-over sequences comprising outpatient chemotherapies, vinorelbine/cyclophosphamide (R1) and temozolomide/etoposide (R2), for relapsed or refractory solid tumors in children and young adults
Scientific Title:Acronym Cross-over rPII of outpatient chemotherapies for refractory pediatric solid tumors
Region
Japan

Condition
Condition Relapse or refractory pediatric solid tumor
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To examine safety and efficacy of weekly vinorelbine (VNR) with daily oral cyclophosphamide (CY)
3. To determine the safety and efficacy of the oral combination chemotherapy comprising temozolomide (TMZ) and etoposide (VP)
3. To explore which regimen between VNR+CY and TMZ+VP be preferable as starting one for survival in outpatient palliative setting for children and young adults with solid tumors refractory to any therapies with labeled drugs in Japan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression free survival (per regimen or per whole protocol therapy), time to treatment failure (1st regimen or whole protocol therapy), response rate, Adverse events profile, self-reported QOL with face scale, number of days attending school/workplace, number of days not attending hospital

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 VNR+CY: weekly intravenous VNR day1,8,15 with daily oral CY, to be repeated every 4 weeks
Interventions/Control_2 TMZ+VP: 5 day schedule oral TMZ and 12 day schedule oral VP, to be repeated every 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
3 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria 1. neuroblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, retinoblastoma, Wilm's tumor, hepatoblastoma, osteosarcoma, other bone or soft tissue sarcoma, primary CNS tumors, germ cell tumors
2. relapse or progression following disease-specific standard chemotherapies
3. evidence of progression in clinical signs or symptoms, of bone marrow metastasis, or of progression or stable disease on imaging studies
4. no prior chemotherapy containing either vinorelbine or temozolomide
5. > 28 days since prior nitrosourea or > 14 days since prior other antitumor cytotoxic agents
6. > 14 days since prior palliative radiation therapy (irradiation dose is less than or equal to 30 Gy) or > 21 days since prior non-palliative irradiation
7. > 14 days since prior surgery (including open biopsy)
8. 0-2 in ECOG PS
9. confirming the following laboratory results within 14 days
(1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 5,000/mm~3 (at least 3days since prior concentrated platelet transfusion)
(3) serum total Bilirubin <= 1.2mg/dl
(4) Creatinine adjusted according to age as follows:
<= 0.6 mg/dl (1 year-23 months)
<= 0.8 mg/dl (2 years-5 years)
<= 0.9 mg/dl (6 years-9 years)
<= 1.1 mg/dl (10 years-12 years [male])
<= 1.0 mg/dl (10 years-12 years [female])
<= 1.5 mg/dl (13 years-15 years [male])
<= 1.2 mg/dl (13 years and over [female])
<= 1.7 mg/dl (16 years and over [male])

10. no difficulty to take 8mm tablet
11. legal adult: Written informed consent
12. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian
13. 15 years and under: written informed consent from legal guardian
Key exclusion criteria 1. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment
2. Active infection requiring systemic medication
3. abnormality in electrocardiogram tested within 28 days, requiring intervention
4. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion
5. Women during pregnancy or breast-feeding
7. Psychosis
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Ogawa
Organization Niigata Cancer Center Hospital
Division name Pediatric Devision
Zip code
Address 2-15-3 Kawagishi-cho, Chuo-ku, Niigata 951-8566, Japan
TEL 025-266-5111
Email atsushi@niigata-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Ogawa
Organization study coordinator
Division name Niigata Cancer Center Hospital pediatric division
Zip code
Address 15-3, kawagishicho 2chome, Chuo-ku, Niigata 951-8566, Japan
TEL 025-266-5111
Homepage URL http://www.nposuccess.jp/datacenter/
Email atsushi@niigata-cc.jp

Sponsor
Institute Group for " Cross-over rPII of outpatient chemotherapies for refractory pediatric solid tumors "
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立がん研究センター中央病院(東京都)
国立がん研究センター東病院(茨城)
日本大学医学部附属板橋病院(東京都)
埼玉県立小児医療センター(埼玉県)
国立がんセンター東病院(千葉県)
静岡県立静岡がんセンター(静岡県)
新潟県立がんセンター新潟病院(新潟県)
大阪市立総合医療センター(大阪府)
滋賀医科大学附属病院(滋賀県)
鹿児島大学医学部附属病院(鹿児島県)
愛知県がんセンター中央病院(愛知県)
兵庫県立こども病院(兵庫県)
福島県立医科大学付属病院(福島県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2014 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 09 Day
Last modified on
2015 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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