UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032591
Receipt number R000037104
Scientific Title The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.
Date of disclosure of the study information 2018/05/15
Last modified on 2019/05/15 16:14:36

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Basic information

Public title

The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.

Acronym

The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.

Scientific Title

The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.

Scientific Title:Acronym

The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the safety and efficacy of olanzapine for nausea and vomiting which was induced by oxaliplatin-chemotherapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

The rate of adverse events

Key secondary outcomes



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

Olanzapine; 5mg PO on days 1 to 4
Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3
5HT3-receptor antagonist; IV administration on day 1
Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 3

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Oxaliplatin-naive patients who receive the oxaliplatin (>=85mg/m2)-based chemotherapy
2. no limitation in TNM stage, recurrence, or metastatic unresectable.
3. no limitation of use of targeted therapy
4. Enough organ functions
5. Written informed consent

Key exclusion criteria

1. Patients who has severe dysfunction of liver or kidney
2. Patients who suffered nausea or vomiting before 24 h of the enrollment
3. Patients who used antiemetics before 24 h of the enrollment
4. Patients with symptomatic brain metastasis/carcinomatosis.
5. Patients who had diabetes.
6. Pregnant, breastfeeding or expecting woman.
7. Patient is receiving pimozide
8. Patient is judged inappropriate by the investigator as subject for this study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Nishimura, and Akiko Hasegawa

Organization

Osaka International Cancer Institute

Division name

Department of Gastroenterological surgery, and Clinical Oncology

Zip code


Address

3-1-69, Otemae, Osaka city, Osaka, Japan

TEL

0669451181

Email

jnishimura@gesurg.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Nishimura

Organization

Osaka International Cancer Institute

Division name

Department of Gastroenterological surgery

Zip code


Address

3-1-69, Otemae, Osaka city, Osaka, Japan

TEL

0669451181

Homepage URL


Email

jnishimura@gesurg.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



Funding Source

Organization

Osaka International Cancer Institute

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

2018 Year 05 Month 15 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

No longer recruiting

Date of protocol fixation

2018 Year 05 Month 08 Day

Date of IRB

2018 Year 05 Month 10 Day

Anticipated trial start date

2018 Year 05 Month 14 Day

Last follow-up date

2019 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 14 Day

Last modified on

2019 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037104


Research Plan
Registered date File name
2018/11/12 オランザピン研究計画書 確定 第2版.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name