UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010638 |
|---|---|
| Receipt number | R000012439 |
| Scientific Title | Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2019/03/08 09:56:15 |
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Basic information
Public title
Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Acronym
JACCRO CC-08 study
Scientific Title
Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Scientific Title:Acronym
JACCRO CC-08 study
Region
| Japan |
Condition
Condition
metastatic 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 cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer showing clinical response (CR, PR, or SD continuing 6 months or more) in the first-line cetuximab containing therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-Month Progression Free Survival Rate
Key secondary outcomes
Response Rate
Disease Control Rate
Overall Survival
Progression Free Survival
Time to Treatment Failure
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
cetuximab (first time) 400mg/m2/week,
cetuximab (after 2nd time) 250mg/m2/week,
irinotecan 150mg/m2/bi-weekly
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 histologically proven colorectal cancer.
2) KRAS wild-type
3) Patients shouwing clinical response (CR, PR or SD continuing 6 months or longer) in first-line cetuximab combination therapy.
4) First-line therapy with oxaliplatin and second-line therapy with irinotecan, or first-line therapy with irinotecan and second-line therapy with oxaliplatin.
5) Patients with second-line therapy except anti-EGFR antibody.
6) Presence of evaluable lesion defined by RECIST criteria.
7) ECOG Performance status 0-2
8) Age 20 years or older
9) Life expectancy of 3 months or longer
10) Patients have enough organ function for study treatment assesed within 14 days before treatment.
11) Written informed consent.
Key exclusion criteria
1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
2) Symptomatic brain metastases.
3) Severe infectious disease.
4) Comorbidity or history of interstitial lung disease or pulmonary fibrosis.
5) Comobidity or history of severe heart failure.
6) Sensory alterration or paresthesia interfering with function.
7) Large quanity of pleural, abdominal or cardiac effusion.
8) Severe comobidity (renal failure, liver failure, hypertension, etc.)
9) Prior radiotherapy for primary and metastatic tumors.
10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
11) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Tsuji |
Organization
Kobe City Medical Center General Hospital
Division name
Clinical oncology
Zip code
Address
2-1-1 Minatojima-minamimachi, Chuo-Ku, Kobe 650-0047, Japan
TEL
078-302-4321
tsuji@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Office
Zip code
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
cc08.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Research Organization
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
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
神戸市立医療センター中央市民病院（兵庫県）ほか、JACCRO参加施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2013 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 16 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012439
