UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006583 |
|---|---|
| Receipt number | R000007797 |
| Scientific Title | Multicancer Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer |
| Date of disclosure of the study information | 2011/10/21 |
| Last modified on | 2014/10/21 09:08:27 |
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Basic information
Public title
Multicancer Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Acronym
Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for rectal cancer (FACT)
Scientific Title
Multicancer Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Scientific Title:Acronym
Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for rectal cancer (FACT)
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Preoperative respose rate
Key secondary outcomes
Pathological evaluation, R0 resection rate, Pathological complete respose rate, Down stage rate, Adverse events, The percentage of patients who complete scheduled treatment, Incidence of surgical morbidity and mortality
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
Fluororacil / l-leucovorin plus oxaliplatin (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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Stage II / III rectal caner
2. Depth invasion: T3 or T4
3. No prior surgery for rectum
4. No prior chemotherapy for rectal cancer
5. No prior radiotherapy
6. Age: 20-80
7. Performance status(ECOG): 0-1
8. Adequate bone marrow, liver and renal functions
9. Patients who can perform an surgery for rectum 2-6 weeks after chemotherapy.
10. Written informed concent.
Key exclusion criteria
1. Comorbidity of active double cancer
2. Peripheral sensory nerve disorder
3. Poor controled hypertension
4. Poor controled diabetes mellitus
5. Severe electrocardiographic abnormality or comorbidity of poor controled heart failure
6. Comorbidity of severe pulmonary diease
(interstitial lung disease, pulmonary
fibrosis, emphysema pulmonum and so on)
7. Poor controlled psychiatric disorder
or history of central nervous system disorder
8. Watery diarrhea
9. Treated continuously with systemic steroids
10. Pregnant or lactating women or women childbearing potential
11. Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kameoka |
Organization
Tokyo Women's Medical University Hospital
Division name
Surgery 2
Zip code
Address
8-1, KAWATACHO, SHINJYUKU-KU, TOKYO
TEL
03-3353-8111
itabashi@surg2.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Itabashi MD |
Organization
FACT Investigator Group
Division name
Tokyo Women's Medical University Hospital
Zip code
Address
8-1, KAWATACHO, SHINJYUKU-KU, TOKYO
TEL
03-3353-8111
Homepage URL
itabashi@surg2.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Hospital
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
FACT Investigator Group
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 21 | 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
| 2011 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | 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
| 2011 | Year | 10 | Month | 21 | Day |
Last modified on
| 2014 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007797
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| Registered date | File name |
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