UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination chemotherapy with gemcitabine plus oxaliplatin in patients with refractory germ cell cancer
Title of the study (Brief title)	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	Yoichi Arai
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Urology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL	+81-22-717-7278
Email	yarai@uro.med.tohoku.ac.jp

Public contact
Name of contact person	Shigeyuki Yamada
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Urology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL	+81-22-717-7278
Homepage URL
Email	shige-yamada@uro.med.tohoku.ac.jp

Sponsor
Institute	Department of Urology, Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020247