UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004659 |
|---|---|
| Receipt number | 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 09:33:58 |
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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
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
Sponsor or person
Institute
The University of Tokushima Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005550
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