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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016416
Receipt No. R000019063
Scientific Title PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Date of disclosure of the study information 2015/02/02
Last modified on 2018/03/29

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Basic information
Public title PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Acronym PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Scientific Title PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Scientific Title:Acronym PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of mFOLFOX6 in gastric cancer refractory to standard therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate assessed by independent review committee
Key secondary outcomes Disease control rate, progression free survival, overall survival, adverse events, quality of life

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mFOLFOX6
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) Histologically confirmed adenocarcinoma of gastric or esophagogastric junction.
2) Presence of inoperable recurrent or metastatic disease.
3) Received fluoropirimidines, cisplatin and either taxanes and irinotecan before as anticancer treatment for advanced gastric cancer.
4) Male or female patients >=20 years old at the time of informed consent.
5) ECOG performance status of 0 or 1.
6) Presence of at least one measurable disease as defined by RECIST version 1.1.
7) Written informed consent.
Key exclusion criteria 1) Patients with symptomatic brain metastases.
2) Requires perodial drainage of pleural fluid, ascites or pericardial effusion.
3) Received chemotherapy, radiotherapy, surgical or any other experimental therapies as anticancer treatment within 14 days before the first administration of this trial.
4) Previous treatment with oxaliplatin.
5) Concurrent uncontrolled medical condition including active infection, hypertension, diabetes mellitus, pulmonary, cardiac or psychiatric disease
5) known or suspected of not being able to comply with this trial protocol.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigenori Kadowaki
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL 052-762-6111
Email skadowaki@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichiro Mitani
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL 052-762-6111
Homepage URL
Email smitani@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization None
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
2015 Year 02 Month 02 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 Completed
Date of protocol fixation
2015 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 02 Day
Last follow-up date
2018 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 03 Month 11 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 02 Day
Last modified on
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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