UMIN-CTR Clinical Trial

Public title

Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study

Acronym

Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study(POPLAR Study)

Scientific Title

Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study

Scientific Title:Acronym

Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study(POPLAR Study)

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the effect and safety of pregabalin on neurotoxicity of FOLFOX or XELOX for patients with metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Neurotoxicity frequency of accumulation dose 500mg/m2 of L-OHP (Grade2 or more)

Key secondary outcomes

1)Median dose of L-OHP
2)nerve disorder at the end of oxaliplatin-based regimen (each course Grade)
3)the psychometric properities of the FACT/GOG-Ntx
4)PFS and TTF
5)response rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pregabalin is administered during FOLFOX or XELOX therapy.
Initial dose:75mg twice daily(150mg/day),increased to 300 - 600mg/day if there was persistent paresthesia or functional impariment(Grade2 or more).

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically confirmed adenocarcinoma of the colon and rectum
2)No prior chemotherapy,immunotherapy and radiotherapy
3)Age 20<=years
4)Life expectancy at least 12 weeks
5)more than 2 weeks after surgical operation(more than 4 weeks with bevacizumab)
6)Performance Status(ECOG) 0-1
7)without any disorder in the important organs and with good results of the Examinations seven days before the registeration
8)patients who can take food orally
9)written informed consent

Key exclusion criteria

1)Patients who had received blood transfusion, blood products , or hematopoietic growth factors such as granulocyte-colony stimulating factor(G-CSF) within 7 days prior to registration
2)with brain metastasis
3)with much cavity fluid to be removed
4)with active double cancer
5)allergy against medicines
6)uncontrolled Hypertension
7)Prior or current thrapy for neuropathy or sensory dysfunction.
8)uncontrolled DM
9)active infection desease
10)watery diarrhea
11)disorderon EKG
12)severe respiratory disease(interstital pneumonitis,plumonary fibrosis,Severe pulmonary emphysema)
13)psychiatric disorder
14)fresh bleeding on the digestive tract
15)pregnant and/or nursing women
16)Doctor's stop not to be registered

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Satohsi Hirai

Organization

Toyama Prefectural Central Hospital

Division name

Department of outpatient chemotherapy and Gastroenterological medicine

Zip code

Address

2-2-78 Nishinagae,Toyama-shi,Toyama-ken,930-8550

TEL

076-424-1531

Email

Name of contact person

1st name
Middle name
Last name	Satohsi Hirai

Organization

Toyama Prefectural Central Hospital

Division name

Department of outpatient chemotherapy and Gastroenterological medicine

Zip code

Address

2-2-78 Nishinagae,Toyama-shi,Toyama-ken,930-8550

TEL

076-424-1531

Homepage URL

Email

sh915@bc5.so-net.ne.jp

Institute

Toyama Prefectural Central Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

富山県立中央病院　外来化学療法科/内科(消化器)

Date of disclosure of the study information

2012

Year

12

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

08

Month

26

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

12

Month

03

Day

Last modified on

2013

Year

03

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010922