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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005336
Receipt No. R000006249
Scientific Title A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer
Date of disclosure of the study information 2011/04/01
Last modified on 2016/10/06

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Basic information
Public title A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer
Acronym PanSIR study
Scientific Title A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer
Scientific Title:Acronym PanSIR study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 valuation of efficacy and safety profile for combination therapy of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes phase I: Estimated percentage of dose-limiting toxicity at first course.
phase II: Response rate
Key secondary outcomes frequency of Adverse events
Progression-free survival
Overall survival
Treatment completion rate
Time to treatment failure

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 S-1 80mg/m2 Oral administration day1-15 Irinotacan 150mg/m2 90min div day 1 Panitumumab 9mg/m2 90-30min div day 1
A single course to three weeks.
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) Patients who have diagnosis of colorectal cancer by pathological findings are included.
2) Patients who have unresectable advanced or incipient or recurrent cancer are included.
3) Patients who have cancer with KRAS wild type are included.
4) Patients who have measurable lesions are included.
5) Patients who do not have past histories of chemotherapy.
6) Patients who do not have past histories of treatment by CPT-11 and panitumumab or cetuximab are included.
7) Patients who are over 20 year old and would expect survival over 3 months after registration are included.
8) Patients who are under 2 ECOG performance status are included.
9) Patients who have adequate bone marrow and organ functions are included.
10) UGT1A1 genetic polymorphism
11)Patients who are able to oral administration are included.
12)Patients who have adequate heart function in 28 days before registration are included.
13) Patients who are written informed consent are included.

Key exclusion criteria 1) Patients who have allergy for drugs are excluded.
2) Patients who have other malignancies are excluded.
3) Patients who have infections in active are excluded.
4) Patients who have past histories of bowel perforation and / or bowel obstruction in one year before registration are excluded.
5) Patients who have severe diseases are excluded.
6) Patients who have pleural effusion and / or ascites to need treatment are excluded.
7) Patients who have watery diarrhea are excluded.
8) Patients who recieve atazanavir or flucytosin are excluded.
9) Patients who have symptomatic brain metastasis are excluded.
10) Patients who have pregnancy are excluded.
11) Patients who have heavy psycological symptoms are excluded.
12) Patients who receive steroid continuously are excluded.
13) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded.
14) The patient that a study responsibility physician judged to be inappropriate.
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumu Goto MD. PhD.
Organization Yokohama City University Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email ayumu16g@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumu Goto MD. PhD.
Organization Yokohama City University Hospital
Division name Clinical Oncology division
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email ayumu16g@yokohama-cu.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery
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 横浜市立大学附属病院(神奈川県)
神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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
The dose-limiting toxicities occurred in one patients.

Acute pancreatitis as DLT occurred in ninth patient.

The recommended dose was determined to be 9.0mg/kg of Panitumumab.

One patient had grade 3 diarrhea. None of patients had grade 3 or more severe acneiform. And two grade 3 or 4 hypomagnesemia observed.
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 Completed
Date of protocol fixation
2010 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2014 Year 11 Month 30 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 03 Month 29 Day
Last modified on
2016 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006249

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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