UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015065 |
|---|---|
| Receipt number | R000017528 |
| Scientific Title | Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2014/09/05 11:47:42 |
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Basic information
Public title
Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer
Acronym
Evaluation for effects from dosage adjustment caused by skin toxicity in Panitumumab treatment for metastatic colorectal cancer
Scientific Title
Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer
Scientific Title:Acronym
Evaluation for effects from dosage adjustment caused by skin toxicity in Panitumumab treatment for metastatic colorectal cancer
Region
| Japan |
Condition
Condition
Metastatic Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of dose adjustment based on original self-check sheet for skin toxicity in the standard chemotherapy with panitumumab for the patients with unresectable metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Quality of life of the patient, response rate, total dosage and duration of Panitumumab
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
mFOLFOX6+Panitumumab therapy is performed until PD. And dosage of Panitumumab is adjusted according to skin toxicity measured by self-check sheet before each therapy.
Oxaliplatin 85mg/m2
5FU 400mg/m2 bolus, 2400mg/m2 continuous drip
Levofolinate 200mg/m2
Panitumumab 6mg/kg
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. Histologically proved colorectal cancer (adenocarcinoma)
2. Unresectable advanced or recurrent colorectal cancer
3. KRAS wild type
4. Anticancer drug-naive when consent gained
5. ECOG performance status of 0-2
6. Measureable region evaluable according to the RECIST of CT or MRI
7. Life expectancy of at least 2 months
8. Major organ function within 2 weeks of enrollment have met the following criteria.
(1) WBC >= 3,000/mm3 and WBC < 12,000/mm3
(2) Neutrophil >= 1,500/mm3
(3) Platelet >= 100,000/mm3
(4) Hemoglobin concentration >= 8.0g/dL
(5) AST and ALT <= 100IU/L
(6) Total bilirubin <= 2.0mg/dL
(7) Ccr >= 50mL/min or serum creatinine < 1.2mg/dL
Without measurement to use Cockcroft-Gault Ccr=[(140-age)*body weight]/(72*serum creatinine)(if female *0.85)
9. Written consent of the patient has been obtained
Key exclusion criteria
1. Presence of severe drug allergy
2. Administration contraindication of using drugs
3. Antiplatelet or anticoagulant cannot be discontinued
4. Active infectious disease causing fever more than 38 deg C
5. Active gastrointestinal bleeding
6. Serious comorbidities (ileus, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, severe renal failure and liver failure etc.)
7. Pleural effusion or ascites that drainage is needed for
8. Other active malignancies those DFS is within 5 years (except for carcinoma in situ that was confirmed cured by local treatment)
9. Women of childbearing potential, women in pregnancy or lactation and patients who have desire to bear children
10. Investigator deems inappropriate to participate in the test
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwasaki |
Organization
Gifu Prefectual Tajimi Hospital
Division name
gastroenterology
Zip code
Address
5-161, Mehatacho, Tajimi City, Gifu Prefecture, 507-8522, Japan
TEL
0572-22-5311
iwasaki-hiroyasu@tajimi-hospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwasaki |
Organization
Gifu Prefectual Tajimi Hospital
Division name
gastroenterology
Zip code
Address
5-161, Mehatacho, Tajimi City, Gifu Prefecture, 507-8522, Japan
TEL
0572-22-5311
Homepage URL
iwasaki-hiroyasu@tajimi-hospital.jp
Sponsor or person
Institute
Gifu Prefectual Tajimi Hospital
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
岐阜県立多治見病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 05 | Day |
Last modified on
| 2014 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017528
