UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009583 |
|---|---|
| Receipt number | R000011245 |
| Scientific Title | Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery |
| Date of disclosure of the study information | 2012/12/25 |
| Last modified on | 2015/12/25 13:59:36 |
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Basic information
Public title
Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery
Acronym
Phase II of NAC with mFOLFOX6 (+ Cmab)
Scientific Title
Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery
Scientific Title:Acronym
Phase II of NAC with mFOLFOX6 (+ Cmab)
Region
| Japan |
Condition
Condition
Recurrent rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of mFOLFOX6+cetuximab therapy (KRAS wild-type) and mFOLFOX therapy (KRAS mutant-type) in patients with recurrent rectal cancer which has resectable pelvic recurrences
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Disease-free survival
Overall survival
Safety
Response rate
Histological Response
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 | Maneuver |
Interventions/Control_1
1)KRAS wild-type: mFOLFOX6 + cetuximab
2)KRAS mutant-type: 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)A pelvic recurrence after rectal cancer surgery is proved histologically or diagnosed by an imaging
2)Resectable pelvic recurrence by pre-operative examination
3)No prior FOLFOX therapy
4) Patients with radiotherapy history are included
5) No evidence of distant metastasis
6)Age over 20 years
7)ECOG Performance Status (PS) 0-1
8)Written informed consent
9) Adequate organ function
i)Leucocyte count: more than 3,000, less than 12,000 /mm3
ii)Platelet : more than 100,000 / mm3
iii)Serum total bilirubin : less than 1.5 mg / dl
iv)AST : less than 100 U/l
v) ALT : less than 100 U/l
vi)Serum creatinine : less tahn 1.2 mg / dl
Key exclusion criteria
1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
2) Severe infectious disease
3) Patients who receive steroid continuously are excluded
4) Unstable angina or myocardial infarction within 6 months
5) Interstitial pneumonia or fibroid lung
6) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
7) Those considered inappropriate for participation in this trial.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Saito |
Organization
National Cancer Center Hospital East
Division name
Colorectal Surgery Division, Dept of Surgical Oncology
Zip code
Address
6-5-1 Kashiwanohara, Kashiwa, Chiba
TEL
0471-33-1111
norsaito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Kobayashi |
Organization
National Cancer Center Hospital East
Division name
National Colorectal Surgery Division, Dept of Surgical Oncology
Zip code
Address
6-5-1 Kashiwanohara, Kashiwa, Chiba
TEL
0471-33-1111
Homepage URL
akobayas@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院（東京都）
大阪府立成人病センター（大阪府）
愛知県がんセンター中央病院（愛知県）
山形県立中央病院（山形県）
新潟県立がんセンター新潟病院（新潟県）
石川県立中央病院（石川県）
四国がんセンター（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 19 | Day |
Last modified on
| 2015 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011245
