UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018217 |
|---|---|
| Receipt number | R000021085 |
| Scientific Title | A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2020/07/21 10:22:38 |
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Basic information
Public title
A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER
Acronym
JACCRO CC-13 study
Scientific Title
A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER
Scientific Title:Acronym
JACCRO CC-13 study
Region
| Japan |
Condition
Condition
Measurable advanced colorectal cancer with RAS wild-type ( KRAS exon 2,3,4; NRAS exon 2,3,4)
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To verify the advantage of FOLFOXIRI plus cetuximab against FOLFOXIRI plus bevacizumab as the first-line therapy in advanced colorectal cancer patients with RAS wild-type tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
DpR: Deepness of Response
Key secondary outcomes
ETS: Early Tumor shrinkage
RR: Response Rate
DpR: Deepness of Response (at 4 weeks)
TTF: Time to Treatment Failure
TTG: Time to Tumor Growth
PFS: Progression-Free Survival
OS: Overall Survival
Correlation between tumor shrinkage(ETS, RR, DpR) and prognosis(PFS, OS)
Correlation between TTG and OS
Resection rate
R0 resection rate
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOLFOXIRI+Bevacizumab (until 12 courses)
5-FU+Levofolinate+Bevacizumab (after 13 courses)
Bevacizumab 5mg/kg/bi-weekly
Irinotecan 150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
Levofolinate 200mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly
Interventions/Control_2
FOLFOXIRI+Cetuximab (until 12 courses)
5-FU+Levofolinate+etuximab (after 13 courses)
Cetuximab (first time) 400 mg/m2/week
Cetuximab (after 2nd time) 250 mg/m2/week
Irinotecan 150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
Levofolinate 200mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly
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) Histologically confirmed colorectal cancer.
(2) RAS wild-type.
(3) Measurable leision by RECIST.(Ver.1.1)
(4) No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence leision after operation.
(5) Age; more than 20 years old.
(6) ECOG Performance status 0-1.The case >=71 years is PS0.
(7) Life expectancy of more than 6 months.
(8) Patiens have enough organ function for study treatment within 14 days before enrollment;
1) WBC>=3,000/mm3, <12,000/mm3.
2) Neu>=1,500/mm3.
3) PLT>=10.0x104/mm3.
4) Hb>=9.0g/dL.
5) Total Bilirubin<=1.5xULN.
6) AST<=2.5xULN.
7) ALT<=2.5xULN.
8) Creatinine<=1.5xULN.
9) Proteinuria<=1+.
10) PT-INR<=1.5.
(9) Written informed consent.
Key exclusion criteria
(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Suspicious of Lynch syndrome (3) Brain metastases. (4) Infectious disease. (5) Interstitial lung disease or pulmonary fibrosis. (6) Comorbidity or history of serious heart failure. (7) History of thromboembolic events. (8) Cerebrovascular disease. (9) History of hemoptysis/hematemesis. (10) Uncontrolled hypertension.(systolic BP>180mmHg, or diastolic BP>100mmHg) (11) Sensory alteration or paresthesia interfering with function. (12) Large quantity of pleural, abdominal or cardiac effusion. (13) Severe comorbidity (renal failure, liver failure, hypertension, etc) (14) Prior radiotherapy for primary and metastases leision. (15) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (16) History of severe allergy. (17) HBsAg positive or active viral hepatitis. (18) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (19) Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 28 days. (20) Systemaic administration of antiplatelet drug or NSAIDs. (21) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (22) History of gastrointestinal perforation within 1 year. (23) Unhealed traumatic bone fracture. (24) Uncontrolled diarrhea. (25) History of organ recipient . (26) Prior cetuximab/bevacizumab/Irinotecan/Oxaliplatin treatment.(Adjuvant therapy by Oxaliplatin is excluded) (27) Administration of atazanavir sulfate. (28) Jaundice. (29) Ileus or bowel obstruction. (30) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Tsuji |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Clinical Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
087-898-5111
atsuji@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Office
Zip code
104-0061
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
cc13.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
Merck Serono Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization Institutional Review Board
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel
03-5579-9882
jaccro@jaccro.or.jp
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
香川大学医学部附属病院（香川県）他
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 15 | 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
359
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021085
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