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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004991
Receipt No. R000005934
Scientific Title Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan
Date of disclosure of the study information 2011/02/26
Last modified on 2017/02/05

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Basic information
Public title Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan
Acronym Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment for metastatic CRC in Japan (PaFF-J)
Scientific Title Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan
Scientific Title:Acronym Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment for metastatic CRC in Japan (PaFF-J)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with KRAS wild type, metastatic colorectal cancer in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate (ORR)
Key secondary outcomes - Safety
- Progression free survival (PFS)
- Overall survival (OS)
- Time to progression (TTP)
- Time to treatment failure (TTF)
- Disease control rate
- R0-resection rate
- Histological investigation of the post-treatment liver tissues
- Correlation between clinico-pathological factors and efficacy

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 The investigators choose the treatment A or Barbitrarily.
A: FOLFOX + panitumumab
B: FOLFIRI + panitumumab
Repeat every 14 days until meeting the withdrawal criteria.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Coloretal cancer (adenocarcinoma)
2) Unresectable
3) KRAS wild type
4) Age: 20-80 years old
5) ECOG performance status: 0-1
6) >=1 measurable lesion (at <=30 days prior to enrollment)
7) No prior chemotherapy and radiation thrpy (ex. adjuvant chmotherpy completed <=180 days prior to enrollmet)
8) Adequate organ functions as listed below (at <=14 days prior to enrollment)
i) WBC: 3,000/mm3 to 12,000/mm3
ii) Neutrophl: >=1,500/mm3
iii) Plt: >=100,000/mm3
iv) Hb: >=9.0g/dL
v) T-Bil: <=1.5mg/dL
vi) AST(GOT): <=100*IU/L
vii) ALT(GPT): <=100*IU/L
*patients with liver metastas: <=200IU/L
viii) Creatinine: <=1.2mg/dL
9) Expected survival >=3 months
10) Written informed concent
Key exclusion criteria 1) Prior severe drug allergy
2) Synchronous and/or metachronous multiple cancers
3) Severe bowel stenosis by the primary tumor (ex. after colostomy)
4) Prior adjuvant chemotherapy with oxaliplatin containing regimen
5) Surgical procedure within 28 days prior to enrollment (ex. venous reservoirs implant, colostomy)
6) Severe comorbidity:
- severe pulmonary dysfunction
- Uncontrolled DM
- Uncontrolled HT
- severe cardiovascular disease
- Cirrhosis and liver failure
- Renal failure
7) Sensory neuropathy
8) Severe diarrhea
9) Active infection
10) Symptomatic pleural effusion or ascites
11) Contraindications to 5-FU, l-LV, panitumumab, L-OHP or CPT-11
12) Concerning pregnancy
13) The investigator considers not suitable for the study
Target sample size 165

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Sugihara, M.D., PhD
Organization Tokyo Medical and Dental University, Graduate School
Division name Dept. of Surgical Oncology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL 03-5803-5261
Email k-sugi.srg2@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Sugihara, M.D., PhD
Organization Tokyo Medical and Dental University, Graduate School
Division name Dept. of Surgical Oncology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL 03-5803-5261
Homepage URL http://www.ibri-kobe.org/
Email k-sugi.srg2@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2011 Year 02 Month 26 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 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
2011 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 10 Month 28 Day
Date trial data considered complete
2015 Year 12 Month 23 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 01 Day
Last modified on
2017 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005934

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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