UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008496 |
|---|---|
| Receipt number | R000009916 |
| Scientific Title | A Phase II trial of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer |
| Date of disclosure of the study information | 2012/07/23 |
| Last modified on | 2016/03/11 12:48:40 |
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Basic information
Public title
A Phase II trial of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer
Acronym
TOHOKU POWER trial
Scientific Title
A Phase II trial of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer
Scientific Title:Acronym
TOHOKU POWER trial
Region
| Japan |
Condition
Condition
KRAS wild type metastatic colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival,
Disease control rate,
Time to treatment failure,
Duration of response,
Resection rate of metastases,
Adverse events
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
Panitumumab with irinotecan/S-1(IRIS)
S-1,80-120mg/body for twice daily 14 consecutive days followed by 2 weeks rest combined with intravenous CPT-11 100mg/m^2 and P-mab 6mg/kg(weight) given on day1,15 every 4 weeks until disease progression or unmanageable toxicity.
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 proven colorectal cancer.
2. Unresectable advanced/recurrent colorectal cancer.
3. KRAS wild type.
4. Measurable lesions or evaluable lesions are confirmed by CT.
5. Metastatic and/or recurrent disease and no prior chemotherapies.
6. No prior chemotherapy involving L-OHP, CPT-11, Panitumumab or Cetuximab.
7. Age>=20 and life expectancy of more than 3 months.
8. Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1.
9. Patients who have adequate bone marrow and organ functions are preserved within 14 days prior to entry.
(1)3,000/mm^3 <= WBC < 12,000/mm^3
(2)Neutrophils >= 1,500/mm^3
(3)Platelets >= 100,000/mm^3
(4)Hemoglobin >= 9.0g/dL
(5)Total bilirubin <= 2.0mg/dL
(6)AST(GOT) <= 100IU/L
(7)ALT(GPT) <= 100IU/L
(8)Creatinine < 1.5mg/dL
(9)CCr:>=50mL/min
Ccr(mL/min)=
weight(kg)*(140-age)/72*Creatinine
(mg/dL)
However, woman multiply 0.85.
If 50mL/min <= CCr < 80mL/min,
start dose of S-1 is reduced one
level down.
10. Capability of oral intake.
11. Signed informed consent of the patient for the registration.
Key exclusion criteria
1. Patients who have allergy for drugs.
2. Patients who have other malignancies.
3. Infectuins in active.
4. Patients who have past histories of bowel perforation and/or bowel obstruction in one year before registration.
5. Serious complications (e.g.,interstitial pneumonitis,
pulmonary fibrosis, heart failure, renal failure, hepatic failure or uncontrolled high blood pressure or diabetes mellitus).
6. Pleural effusion and/or ascites to need treatment.
7. Watery diarrhea.
8. Patients who have given a dose of flucytosine or atazanavir sulfate.
9. Patients who have brain metastases.
10. Pregnant woman, nursing mothers, possibly pregnant woman and wishing to become pregnant.
11. Patients who have severe mental disease.
12. The Patient that a study responsibility physician judged to be inappropriate.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Hakamada |
Organization
Hirosaki University Graduate School of Medicine
Division name
Dept. of Gastroenterological Surgery
Zip code
Address
5, Zaifutyou, Hirosaki, Aomori, 036-8562, Japan
TEL
0172-39-5079
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Koyama |
Organization
Hirosaki University Graduate school of Medicine
Division name
Dept. of Gastroenterological Surgery
Zip code
Address
5, Zaifutyou, Hirosaki, Aomori, 036-8562, Japan
TEL
0172-39-5079
Homepage URL
Sponsor or person
Institute
Tohoku-Six Universities Research Group by Experts(T-SURGE)
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
弘前大学大学院医学研究科 消化器外科学講座（青森県）
秋田大学大学院医学系研究科 消化器外科講座（秋田県）
岩手医科大学 外科学講座（岩手県）
東北大学大学院医学系研究科 外科病態学講座 先進外科学分野（旧第二外科）（宮城県）
東北大学大学院医学系研究科 外科病態学講座 消化器外科学分野（肝胆膵外科）（宮城県）
山形大学医学部 消化器・一般外科 乳腺・甲状腺外科（山形県）
福島県立医科大学医学部 器官制御外科学講座（福島県）
福島県立医科大学医学部 臓器再生外科学講座（福島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 23 | 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
| 2012 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2016 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009916
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
