UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010589 |
|---|---|
| Receipt number | R000012330 |
| Scientific Title | A phase II study of TEGAFOX as adjuvant therapy for elderly patients with stage III and stage II colorectal cancer with risk factors for recurrence. |
| Date of disclosure of the study information | 2013/04/30 |
| Last modified on | 2019/10/29 09:18:59 |
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Basic information
Public title
A phase II study of TEGAFOX as adjuvant therapy for elderly patients with stage III and stage II colorectal cancer with risk factors for recurrence.
Acronym
A phase II study of TEGAFOX as adjuvant therapy for with stage III and stage II colorectal cancer with risk factors for recurrence.
Scientific Title
A phase II study of TEGAFOX as adjuvant therapy for elderly patients with stage III and stage II colorectal cancer with risk factors for recurrence.
Scientific Title:Acronym
A phase II study of TEGAFOX as adjuvant therapy for with stage III and stage II colorectal cancer with risk factors for recurrence.
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the TEGAFOX followed by UFT/LV for patients with stage III and stage II colon cancer with risk factors of recurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feasibility
Key secondary outcomes
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
UFT 300mg per m2 per day and LV 75mg per day for 28 days
Oxaliplatin:85mg/m2 day1,15
every 5-weeks for 3-cycle
After this therapy, followed by UFT/LV
2-cycle
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)with histologically confirmed colorectal cancer
2)with histologically confirmed stageIII and stageII colorectal cancer stageII:has at least one of the following factors
-ileus
-vascular invasion-positive
-T4
-poorly differentiated adenocarcinoma or undifferentiated carcinoma
-perforaiton
-lymph node dissection:less than 12
3)>=D2 lymph node dissection
4)Pathological curability is A or B
5)is aged 70 and over
6)Performance status 0-1
7)Without prior anti-tumor therapy
8)Adequate organ function
9)can start the therapy within 8weeks after surgery.
10)can take drugs orally.
11)whose written consent is taken.
Key exclusion criteria
1)Multiple malignancies within five
years
2) Other severe complications, such as
pulmonary emphysema, pulmonary fibrosis, hyper pulmonary
emphysema,paralysis intestinal,
intestinal obstruction, uncontrollable diabetes, cirrhosis, uncontrollable
hypertension, myocardial infarction
within six months, angina.
3)has severe diarrhea
4)with psychosis or psychoneyrosis
5) In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiko Funahashi |
Organization
Toho University Medical Center Omori hospital
Division name
Depaetment of Gastoroenterological Surgery
Zip code
Address
6-11-1, Omori-nishi Ota-ku, Tokyo, Japan
TEL
03-3762-4151
kingkong@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimihiko Funahashi |
Organization
Toho University Medical Center Omori hospital
Division name
Depaetment of Gastoroenterological Surgery
Zip code
Address
6-11-1, Omori-nishi Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
kingkong@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Medical Center Omori hospital
Institute
Department
Personal name
Funding Source
Organization
Toho University Medical Center Omori 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 30 | 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
| 2013 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012330
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