UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017471 |
|---|---|
| Receipt number | R000020247 |
| Scientific Title | Combination chemotherapy with gemcitabine plus oxaliplatin in patients with refractory germ cell cancer |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2018/12/17 19:41:06 |
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Basic information
Public title
Combination chemotherapy with gemcitabine plus oxaliplatin in patients with refractory germ cell cancer
Acronym
chemotherapy with gemcitabine plus oxaliplatin for refractory germ cell cancer
Scientific Title
Combination chemotherapy with gemcitabine plus oxaliplatin in patients with refractory germ cell cancer
Scientific Title:Acronym
chemotherapy with gemcitabine plus oxaliplatin for refractory germ cell cancer
Region
| Japan |
Condition
Condition
germ cell cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine efficacy and safety of salvage therapy with gemcitabine and
oxaliplatin in patients with refractory germ cell cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
median survival time, progression free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination chemotherapy with gemcitabine, oxaliplatin and paclitaxel
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
1.Patients had to present with histologically confirmed germcell tumors.
2.Refractory was defined as incomplete reduction or elevation of serum tumor marker, or increase in the product of perpendicular diameters for any lesion or the appearance of any new lesions during chemotherapy.Relapse was defined as elevation of serum tumor marker after normalization, or the appearance of any new lesions after disappearance of all evidence of disease.
3. Patients wererequired to have a performance status less than 22 before registration of this study. Additional eligibility criteria included adequate
major organ function, defined as a lneutrocyte count of 1000,/mm3, a thrombocyte count of 50,000/mm3, serum creatinine level less than 1.5 times the upper limit of normaland a liver enzyme level less than 2.5 times the upper limit of normal.
Key exclusion criteria
1.patient with symptomatic interstitial pneumonia
2.patient with grade 3 or 4 cardiac insufficiency with NYHA classification
3.patient with severe infection
4.patient with severe comorbidity
5.patient with severe allergy
6.patient with active another malignancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Arai |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
+81-22-717-7278
yarai@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Yamada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
+81-22-717-7278
Homepage URL
shige-yamada@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Urology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 08 | 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
| 2014 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 17 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020247
