UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016416 |
|---|---|
| Receipt number | 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 22:37:35 |
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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
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
smitani@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019063
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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