UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011485 |
|---|---|
| Receipt number | R000013334 |
| Scientific Title | Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2020/08/20 08:12:48 |
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Basic information
Public title
Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer
Acronym
Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer
Scientific Title
Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer
Scientific Title:Acronym
Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer
Region
| Japan |
Condition
Condition
Metastatic Colorectal Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of prophylactic treatments with skin care or skin care/ antibiotics in the patients with unresectable metastatic colorectal cancer who receive standard chemotherapy with panitumumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
incidence rates of skin toxicity (>=Grade2) with or without antibiotics during the 6 weeks from the treatment started
Key secondary outcomes
time to the first appearance of skin toxicity (Grade>=2), incidence rates of skin toxicity(Grade>=3), response rate, disease control rate and progression free survival(each line, each chemotherapy regimen), difference between patients' and doctors' view to the side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group
Panitumumab is administered intravenously in 6mg/kg by biweekly
skin care+antibiotics
Clarithromycin is administered orally
twice a day
Interventions/Control_2
B group
Panitumumab is administered intravenously in 6mg/kg by biweekly
skin care only
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)Histopathological cinfirmation of colorectal cancer (excluding vermiform appendix and proctodeum)
2) KRAS wild type
3) Patients with metastatic colorectal cancer, which is measurable based on RECIST, planned to be treated with a panitumumab containing regimen (each line, each chemotherapy regimen)
4) No previous history of chemotherapy with anti EGFR antibody
5) Age=>20 and<=80
6) ECOG Performance status:0-2
7) Treatment free interval with more than 2 weeks after last chemotherapy and radiotherapy and surgical treatments including evisceration
8) Sufficient organ functions within 14 days prior to entry
i) neutrophils>=1500/ul
ii) platelets>=100,000/ul
iii) Hemoglobin>=9.0g/dl
iv) serum creatinine<=1.5xULN
v) serum Mg>=lower limit of normal
vi) serum Ca>=ower limit of normal
vii) AL-P<=3xULN
(5 x upper limit of normal in case
of liver metastasis)
viii)AST<=3xULN
(5 x upper limit of normal in case
of liver metastasis)
ix)ALT<=3xULN
(5 x upper limit of normal in case
of liver metastasis)
x)Total bilirbin<=1.5xULN
9)No severe complication(especially intestinal obstruction, diarrhea, fever)
10) Expected survival>=3months
11) Written informed consent obtained from the patient
Key exclusion criteria
1)Previous history of chemotherapy
with anti EGFR antibody
2)Contraindications to panitumumab
3)Complications or history of interstitial pneumonia, pulmonary fibrosis
4)Pregnant woman, possibly pregnant woman
5) Contraindications to clarithromycin
6)Any other cases who are not suitable for combination chemotherapy
7) Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamichi Komori |
Organization
Osaka General Medical Center
Division name
Gastroenterological Surgery
Zip code
Address
3-1-56 Mandaihigashi sumiyosi-ku, Osaka 558-8558,Japan
TEL
06-6692-1201
tkomori@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taishi Hata |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL
06-6879-3251
Homepage URL
thata@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2013 | Year | 08 | Month | 14 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013334
