UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Random Phase II Study of Effectiveness of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy in the Patients with Gynecologic Malignancy
Title of the study (Brief title)	Random Phase II Study of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy
Region	Japan

Condition
Condition	Paclitaxel-induced peripheral neuropathy in the patients with gynecological malignancies
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To access efficacy and safety of laftidine and pregabalin, respectively, for paclitaxel-induced peripheral neuropathy in the patients with gynecological malignancies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Adverse event Feasibility

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of lafutidine (oral)
Interventions/Control_2	Administration of pregabalin (oral)
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with gynecological malignancies (cancer in the ovary, peritoneum, tube, cervix, or endometrium) who have paclitaxel-induced peripheral neuropathy 2.Patients scheduled to receive the same regimen as a present regimen during at least 10 weeks 3.Patients obtained informed consent in a documented form
Key exclusion criteria	1.ECOG performance status: 3 or 4 2.Patients with neuropathy due to apparently other causes such as diabetes 3.Patients who have received more than two previous chemotherapy regimen 4.Patients with moderate to severe renal dysfunction (serum creatinine >1.5mg/ml, or creatinine clearance <30ml/min) 5.Patients with severe congestive heart failure 6.Patients with angioedema 7.Patients who have been administered laftidine or pregabalin previously for peripheral neuropathy 8.Patients taking any antidepressants or any anticonvulsants 9.Patients for whom completion of this study is deemed inappropriate for any reason
Target sample size	80

Research contact person
Name of lead principal investigator	Hiroaki Nagano
Organization	Tokyo Women's Medical University, Medical Center East
Division name	Obstetrics and Gynecology
Address	2-1-10, Nishiogu, Arakawa-ku
TEL	03-3810-1111
Email	naganoog@dnh.twmu.ac.jp

Public contact
Name of contact person	Hiroaki Nagano
Organization	Tokyo Women's Medical University, Medical Center East
Division name	Obstetrics and Gynecology
Address	2-1-10, Nishiogu, Arakawa-ku
TEL	03-3810-1111
Homepage URL
Email	naganoog@dnh.twmu.ac.jp

Sponsor
Institute	Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization	Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	KCOG-G1304
Org. issuing International ID_1	Kansai Clinical Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 02 Day
Anticipated trial start date	2013 Year 11 Month 06 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2016 Year 10 Month 31 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 10 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012494