UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005191 |
|---|---|
| Receipt number | R000005366 |
| Scientific Title | XELOX stop-and-go trial:A phase 2 study of 1st line chemotherapy for unresectable or recurrent colorectal cancer. |
| Date of disclosure of the study information | 2011/03/06 |
| Last modified on | 2012/03/04 17:59:13 |
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Basic information
Public title
XELOX stop-and-go trial:A phase 2 study of 1st line chemotherapy for unresectable or recurrent colorectal cancer.
Acronym
FMOG1001 XELOX stop and Go
Scientific Title
XELOX stop-and-go trial:A phase 2 study of 1st line chemotherapy for unresectable or recurrent colorectal cancer.
Scientific Title:Acronym
FMOG1001 XELOX stop and Go
Region
| Japan |
Condition
Condition
Unresectable or recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 1st line chemotherapy of capecitabine and oxaliplatin (XELOX) stop-and-go schedule in unresectable or recurrent colorectal cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate
Time to treatment failure
Overall survival
Safety plofiles(Rate of Grade 3 neurotoxicity, adverse events)
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
XELOX therapy 6 courses, followed by XELODA 6 courses, then XELOX
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From 25 to 75 years old, colorectal cancer, PS 0-1, chemotherapy naive, proper organ function, not indicated for bevacizumab for some reasons.
Key exclusion criteria
Double cancer, severe allergic history, active infections, severe complications
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eishi Baba |
Organization
Kyushu University Hospital
Division name
Hematology and Oncology
Zip code
Address
3-1-1, Maedashi, Higashi-ku, Fukuokashi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyushu University Hospital
Division name
Hematology and Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hematology and Oncology, Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
| 2011 | Year | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
| 2011 | Year | 03 | Month | 04 | Day |
Last modified on
| 2012 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005366
