UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004654 |
|---|---|
| Receipt number | R000005545 |
| Scientific Title | A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2018/12/10 12:39:48 |
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Basic information
Public title
A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer
Acronym
A phase II study of panitumumab for patients with KRAS wild type colorectal cancer
Scientific Title
A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer
Scientific Title:Acronym
A phase II study of panitumumab for patients with KRAS wild type colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of efficacy and safety profile for treatment of panitumumab for KRAS wild typed colorectal cancer patients who were refractory to satandard regimens
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
frequency of Adverse events
tumor regression rate
Progression-free survival
Overall survival
Treatment completion rate
Time to treatment failure
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 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 have past histories of treatment failures by fluoropyrimidines, irinotecan and oxaliplatin are included.
6) Patients who do not have past histories of treatment by 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) Patients who have adequate heart function in 28 days before registration are included.
11) 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 have symptomatic brain metastasis are excluded.
9) Patients who have pregnancy are excluded.
10) Patients who receive steroid continuously are excluded.
11) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded.
12) Patients whom physicians decide to exclude are ineligible.
13) The patient that a study responsibility physician judged to be inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Endo, 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
endoit@med.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
ayumu16g@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery
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
横浜市立大学附属病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立市民病院（神奈川県）
藤沢市民病院（神奈川県）
横須賀共済病院（神奈川県）
済生会横浜市南部病院（神奈川県）
横浜市立みなと赤十字病院（神奈川県）
横浜掖済会病院（神奈川県）
済生会若草病院（神奈川県）
国立病院機構横浜医療センター（神奈川県）
横浜船員保険病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results of this study demonstrate that tri-weekly panitumumab treatment is a promising regimen offering benefits in terms of convenience and safety in patients with advanced colorectal cancer
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 | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
Either of the following treatment methods are selected.
1) panitumumab(6mg/kg) day 1,q2w until disease progression
2) panitumumab(9mg/kg) day 1,q3w until disease progression
3) panitumumab(6mg/kg) plus FOLFOX day 1,q2w until disease progression
4) panitumumab(6mg/kg) plus FOFIRI day 1,q2w until disease progression
5) panitumumab(6mg/kg) plus CPT-11 day 1,q2w until disease progression
Management information
Registered date
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005545
| Research Plan | |
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| 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 |
