UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012936
Receipt number R000015104
Scientific Title Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer
Date of disclosure of the study information 2014/01/23
Last modified on 2019/01/29 09:24:39

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Basic information

Public title

Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer

Acronym

Perpetual study estimated-by united sections in Gifu for colorectal cancer (PerSeUS CRC-01)

Scientific Title

Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer

Scientific Title:Acronym

Perpetual study estimated-by united sections in Gifu for colorectal cancer (PerSeUS CRC-01)

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Neurotoxicity frequency of cumulative dose 500mg/m2 of oxaliplatin (Grade2 and more)

Key secondary outcomes

1)Cumurative dose to occurrence of neurotoxicity
2)Time to occurrence of neurotoxicity
3)The number of FOLFOX treatment courses
4)Relative dose intensity of oxaliplatin
5)FACT/GOG-Ntx and verval rating scale
6)Adverse events
7)Response rate
8)Progression free survival
9)Time to treatment failure


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

In case of FOLFOX related-peripheral neurotoxicity (Grade1), pregabalin is administered.

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed colorectal cancer.
2)No prior chemotherapy. However, patients with recurrence more than 6 months after completion of adjuvant chemotherapy with other than oxaliplatin were also eligible.
3)ECOG PS of 0 or 1
4)Age ranging between 20 and 75 years old
5)A life expectancy of more than 12 weeks
6)Satisfactory oral feeding
7)Adequate function of vital organs, including bone marrow, heart, lungs, liver and kidneys, laboratory data within 28 days before registration
Neutrophil >=1,500/mm3
Platelet >=100.000/mm3
Hemoglobin >=9.0g/dL
AST and ALT <=100IU/L (<=200IU/L if the patient has liver metastasis)
Total bililbin <=2.0mg/dL
Serum creatinine <=1.5mg/dL
Creatinine clearance >=60mL/min
8)Written informed consent

Key exclusion criteria

1)Serious drug allergy
2)Neuropathy or sensory dysfunction
3)History of oxaliplatin treatment
4)Preventive administration for oxaliplatin-related neuropathy
5)Pain in the arm or foot
6) Current analgesic treatment
7)Active double cancer within the past 5 years
8)A systemic inflammatory condition or serious infection
9)Pregnant or lactating women
10)Serious psychological disease
11)Steroid treatment
12)Blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days
13)Pleural effusion, ascites, or pericardial effusion
14)Clinically significant heart disease
15)Clinically significant pulmonary disease
16)Gastrointestinal bleeding that requires medication or transfusion
17)Watery diarrhea
18)Ileus or bowel obstruction
19)Uncontrolled diabetes mellitus with or without diabetic neuropathy
20) Investigator's judgement

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Yoshida

Organization

Gifu University graduate school of medicine

Division name

Department of surgical oncology

Zip code


Address

1-1 Yanagido, Gifu city, Gifu, Japan

TEL

058-230-6000

Email

kyoshida@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuhisa Matsuhashi

Organization

Gifu University graduate school of medicine

Division name

Department of surgical oncology

Zip code


Address

1-1 Yanagido, Gifu city, Gifu, Japan

TEL

058-246-1111

Homepage URL


Email

nobuhisa517@hotmail.com


Sponsor or person

Institute

PerSeUS: Perpetual Study estimated-by United Sections in Gifu

Institute

Department

Personal name



Funding Source

Organization

Office of PerSeUS

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


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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 23 Day


Related information

URL releasing protocol


Publication of results

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

Completed

Date of protocol fixation

2013 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 04 Day

Last follow-up date

2018 Year 10 Month 30 Day

Date of closure to data entry

2018 Year 10 Month 30 Day

Date trial data considered complete

2018 Year 10 Month 30 Day

Date analysis concluded

2018 Year 10 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 23 Day

Last modified on

2019 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name