UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008496
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Tohoku-Six Universities Research Group by Experts(T-SURGE)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.