UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005196 |
|---|---|
| Receipt number | R000006163 |
| Scientific Title | Combination therapy trial of panitumumab(Pmab) with FOLFIRI for inoperable advanced recurrent colorectal cancer first-line chemotherapy |
| Date of disclosure of the study information | 2011/03/16 |
| Last modified on | 2015/09/07 23:51:07 |
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Basic information
Public title
Combination therapy trial of panitumumab(Pmab) with FOLFIRI for inoperable advanced recurrent colorectal cancer first-line chemotherapy
Acronym
KPUMDS C-02 study
Scientific Title
Combination therapy trial of panitumumab(Pmab) with FOLFIRI for inoperable advanced recurrent colorectal cancer first-line chemotherapy
Scientific Title:Acronym
KPUMDS C-02 study
Region
| Japan |
Condition
Condition
advanced and recurrent colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of FOLFIRI/Panitumumab as a second line chemotherapy for the patients with advanced or recurrent colorectal
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Progression-free survival
Overall Survival
Safety
Efficacy according to B-RAF status (ORR,PFS,OS,Safety)
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
FOLFIRI:irinotecan 150mg/m2, l-LV 200mg/m2
5FU400mg/m2(bolus), 2400mg/m2(infusional)
Panitumumab:6mg/kg
to be repeated every 2 weeks 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with pathologically proven colorectal cancer (adenocarcinoma) and unresectable
2)Patients with tumor resistant/intolerant (failure) to oxaliplatin therapy failure (resistant/intolerant): PD on the therapy of recurrence within 6 months after the adjuvant therapy. Stop of treatment due to allergic reaction, withdrawal neuro-toxicity and/or ohter toxic events
3)genetically proven KRAS wild type on the tumor tissue
4)Performance Status 0-1 (ECOG)
5)with rest period of treatment 4 weeks for radiation therapy, 2 weeks for chemotherapy
6)with a good condition of important organs
1.BM: WBC>3500/mm3, platelet>100,000/mm3
2.hepatic function: total bilirubin >2.0mg/dL, AST/ALT<100IU/L
3.renal function: creatinine <= normal limit of each
Key exclusion criteria
1)A history of CPT-11 use
2)Contraindications to panitumumab
3)Contraindications to irinotecan
1.Severe bone marrow suppression
2.infection
3.Diarrhea
4.intestinal paralysis and intestinal obstruction
5.interstitial pneumonia, pulmonary fibrosis
6.Massive pleural or abdominal effusion
7. Icterus
8.Need to treatment with atazanavir sulfate
9.History of serious drug hypersensitivity "
4)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eigo Otsuji |
Organization
Kyoto Prefectural University of Medicine
Division name
Digestive surgery
Zip code
Address
465 Kajii-cho Kamigyoku, Kyoto city 602-8566
TEL
075-251-5527
otsuji@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Nakanishi |
Organization
Kyoto Prefectural University of Medicine
Division name
Digestive Surgery
Zip code
Address
465 Kajii-cho Kamigyoku, Kyoto city 602-8566
TEL
075-251-5527
Homepage URL
mnakan@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 03 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 03 | Month | 05 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006163
