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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004659
Receipt No. R000005550
Scientific Title A phase 2 study of combination therapy with irinotecan/ S-1 (IRIS) plus panitumumab as second-line chemotherapy for metastatic colorectal cancer
Date of disclosure of the study information 2010/12/02
Last modified on 2013/08/21

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Basic information
Public title A phase 2 study of combination therapy with irinotecan/ S-1 (IRIS) plus panitumumab as second-line chemotherapy for metastatic colorectal cancer
Acronym A phase 2 study of combination therapy with irinotecan/ S-1 (IRIS) plus panitumumab as second-line chemotherapy for metastatic colorectal cancer
Scientific Title A phase 2 study of combination therapy with irinotecan/ S-1 (IRIS) plus panitumumab as second-line chemotherapy for metastatic colorectal cancer
Scientific Title:Acronym A phase 2 study of combination therapy with irinotecan/ S-1 (IRIS) plus panitumumab as second-line chemotherapy for metastatic colorectal cancer
Region
Japan

Condition
Condition colonrectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm the feasibility and effectiveness of IRIS plus panitumumab as second-line chemotherapy for metastatic colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rate of protocol therapy
Key secondary outcomes Response rate
Overall survival
Progression free survival
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 Irinotecan (100 mg/m2) and panitumumab (6 mg/kg) on days 1 and 15 and S-1 (40–60 mg according to body surface area) twice daily for 2 weeks, repeated every 4 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)Histologically proven KRAS wild type colorectal adenocarcinoma
2) with measurable lesions for RECIST criteria
3) patients with tumor resistant/intolerant to irinotecan or recurrence within 6 months after the adjuvant therapy
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1,or 2.
5)No past history of severe interstitial pneumonitis, pulmonary fibrosis
6) with a good condition of important organs
a.Hb >=9.0g/dl
b.WBC>= 3,000/mm3, <=12,000 mm3
c.neutrophil >= 1,500/mm3
d.platelet >= 100,000/mm3
e.total bilirubin <= 1.5mg/dl
f.ALT/AST <= 2.5 times of normal limit
g.creatinine <= 1.2mg/dl
Key exclusion criteria 1)Patients with the past history of severe allergic reactions
2)Patients with the past history of treatment of irinotecan and panitumumab
3) Patient with active double cancer
4)Patient with active infection
5) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
6)Patients with severe interstitial pneumonitis or pulmonary fibrosis
7)Patients with uncontrollable ascites and pleural effusion
8)Patients with diarrhea
9) Patient with regular use of furucytocin or fenytoin
10)Patients with symptomatic brain metastasis
11) pregnant or nursing patient or with intent to bear baby
12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Takayama
Organization The University of Tokushima Graduate School
Division name department of gastroenterology and oncology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city
TEL 088-633-7124
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokushima Graduate School
Division name department of gastroenterology and oncology
Zip code
Address
TEL 088-633-7124
Homepage URL
Email

Sponsor
Institute The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 02 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 Preinitiation
Date of protocol fixation
2010 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 02 Day
Last modified on
2013 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005550

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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