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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024528
Receipt No. R000028208
Scientific Title First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer: A phase II study(OGSG 1602)
Date of disclosure of the study information 2016/12/01
Last modified on 2018/10/25

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Basic information
Public title First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer: A phase II study(OGSG 1602)
Acronym First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unerectable colorectal cancer: A phase II study(OGSG 1602)
Scientific Title First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer: A phase II study(OGSG 1602)
Scientific Title:Acronym First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unerectable colorectal cancer: A phase II study(OGSG 1602)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of first-line single agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer whom the treating oncologist considered standard intensive chemotherapy to be unsuitable.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate (DCR)
Key secondary outcomes Response Rate (RR)
Progression free survival (PFS)
Overall survival (OS)
Time to Treatment Failure (TTF)
Safety : the rate of Grade3/4 toxicity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Panitumumab 6mg/kg intravenously every 2 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed CRC that is not a candidate for curative surgical resection
2) Wild Type RAS
3) Patients with metastatic colorectal cancer have received no previous systemic chemotherapy.
4) Age >= 76 years old or age >= 65 who were not deemed to be candidates for combination chemotherapy in the judgment of the treating investigator
5) Measurable disease according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria (version 1.1)
6) Adequate organ function
7) Life expectancy of at least 90 days from enrollment
8) Written informed consent prior to study-specific screening procedure
9) Who had not received EGFR antibody
Key exclusion criteria 1) Uncontrolled diarrhea
2) Symptomatic Interstitial pneumonia or pulmonary fibrosis
3) Previous palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks
4) History of other malignancy with a disease-free interval <1 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
5) Active infections
6) Serious complications
Uncontrolled diabetes mellitus, Uncontrolled gastrointestinal bleeding, Heart failure(and over NYHA ll), hepatic failure and so on
7) History of serious anaphylaxis
8) Requires continuous treatment with systtematic steroids
9) Psychiatric disability that would preclude study compliance
10)Pregnant or lactating females, and males and females unwilling to use contraception
11) HBs antigen positive
12) Otherwise determined by the investigator to be unsuitable for participation in the study
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Gotou
Organization Osaka Medical College Hospital
Division name Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1211
Email in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Terazawa
Organization Osaka Medical College Hospital
Division name Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1211
Homepage URL
Email terasawat@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit 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 大阪医科大学病院(大阪府)、大阪労災病院(大阪府)、市立東大阪医療センター(大阪府)、関西労災病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、兵庫県立西宮病院(兵庫県)、堺市立総合医療センター(大阪府)。大阪医療センター(大阪府)、関西電力病院(大阪府)、大阪府済生会千里病院(大阪府)、近畿大学(大阪府)、市立伊丹病院(大阪府)、耳原総合病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 12 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
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 09 Day
Last follow-up date
2020 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
2016 Year 10 Month 23 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028208

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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