UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021554
Receipt number R000024855
Scientific Title A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/22 15:36:23

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Basic information

Public title

A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer

Acronym

A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer

Scientific Title

A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer

Scientific Title:Acronym

A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer

Region

Japan


Condition

Condition

HER2-positive unresectable advanced gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive unresectable advanced gastric cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events

Key secondary outcomes

Overall survival, progression-free survival, and response rate


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

Oral fluoropyrimidine (capecitabine or S-1), oxaliplatin and trastuzumab

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. Stage IV or recurrence
2. HER2 positive
3. ECOG PS 0-1
4. LVEF>=50% on echo cardiogram
5. Grade 1 or less for diarrhea, stomatitis, hand-foot syndrome, and sensory peripheral nerve neuropathy
6. Laboratory data
1) Neutrophil>=1,500/microl
2) Platelet>=7,500/microl
3) AST<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
4) ALT<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
5) Creatinine clearance>=30 mL/min

Key exclusion criteria

1. HER2 negative
2. Uncontrolled diabetes
3. Uncontrolled hypertension
4. Unstable angina pectoris
5. Synchronous cancers
6. Systemic infection requiring treatment
7. Fever above 38 degree Celsius
8. A possibility of pregnancy or during pregnancy, or lactating women
9. Continuous systemic administration of steroids
10. Resistance to trastuzumab
11. Peripheral neuropathy Grade 2 or more
12. Oxaliplatin allergy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu MAEDA

Organization

Nagoya University Hospital

Division name

Department of Clinical Oncology and Chemotherapy

Zip code


Address

65 Tsurumai-cho Showa-ku Nagoya

TEL

052-741-2111

Email

maeda-o@med.nagoya-ua.c.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu MAEDA

Organization

Nagoya University Hospital

Division name

Department of Clinical Oncology and Chemotherapy

Zip code


Address

65 Tsurumai-cho Showa-ku Nagoya

TEL

052-741-2111

Homepage URL


Email

maeda-o@med.nagoya-ua.c.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Hospital

Organization

Division

Category of Funding Organization

Other

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

2016 Year 04 Month 01 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

Preinitiation

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 21 Day

Last modified on

2016 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024855


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name