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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018304
Receipt No. R000021189
Scientific Title Randomized phase II study of two cross-over sequences, Gemcitabine/ docetaxel (A) and temozolomide/etoposide (B), for relapsed or refractory Osteosarcoma
Date of disclosure of the study information 2015/07/15
Last modified on 2019/01/16

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Basic information
Public title Randomized phase II study of two cross-over sequences, Gemcitabine/ docetaxel (A) and temozolomide/etoposide (B), for relapsed or refractory Osteosarcoma
Acronym Cross-over rPII study for refractory osteosarcoma
Scientific Title Randomized phase II study of two cross-over sequences, Gemcitabine/ docetaxel (A) and temozolomide/etoposide (B), for relapsed or refractory Osteosarcoma
Scientific Title:Acronym Cross-over rPII study for refractory osteosarcoma
Region
Japan

Condition
Condition Relapse or refractory osteosarcoma
Classification by specialty
Pediatrics Orthopedics Adult
Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy of temozolomide (TMZ) and etoposide (VP) ,Gemcitabine(GEM) and docetaxel(DOC)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-Free Survival
Key secondary outcomes response rate
Overall Survival
Adverse events profile

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TMZ+VP: 5 day schedule oral TMZ and 12 day schedule oral VP, to be repeated every 4 weeks
Interventions/Control_2 GEM+DOC:intravenous GEM day1,8 and DOC day8, to be repeated every 3 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
1 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1.relapsee osteosarcoma
2.relapse or progression following disease-specific standard chemotherapies
3. evidence of progression or stable disease on imaging studies
4.aged 60 or less
5. no prior chemotherapy containing either Gemcitabine, Docetaxel or temozolomide
6.ECOG Performance Status of 0-2
7.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])
8. > 14 days since prior other antitumor cytotoxic agents
9.> 21 days since prior non-palliative chest irradiation or 14 days since prior not palliative radiation therapy
10.Not diagnosed as interstitial pneumonia, pulmonary emphysema nor pulmonary fibrosis with chest CT finding
11. > 7 days since prior surgery (including open biopsy)
12. Written informed consent
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 in pregnant, possibly pregnant or breast feeding
6.Psychiatric disease
7.Inadequate physical condition judged by investigator.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ako Hosono
Organization National Cancer Center Hospital East
Division name Pediatric Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email ahosono@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ako Hosono
Organization National Cancer Center Hospital East
Division name Pediatric Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email ahosono@east.ncc.go.jp

Sponsor
Institute Group for "combination chemotherapies for refractory Adolescent and Young Adult solid tumors "
Institute
Department

Funding Source
Organization Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization Other
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 YES
Study ID_1 609
Org. issuing International ID_1 Niigata Cancer Center Hospital pediatric division
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 14 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021189

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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