UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009802 |
|---|---|
| Receipt number | R000011480 |
| Scientific Title | Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer. phase II multicenter trial. |
| Date of disclosure of the study information | 2013/01/18 |
| Last modified on | 2015/12/02 21:49:44 |
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Basic information
Public title
Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer.
phase II multicenter trial.
Acronym
Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer.
phase II multicenter trial.
(NOBLE Study)
Scientific Title
Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer.
phase II multicenter trial.
Scientific Title:Acronym
Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer.
phase II multicenter trial.
(NOBLE Study)
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer patients who have been either refractory to or intolerant of prior all approved standard chemotherapy.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of the combination of high-dose Bevacizumab Plus Fluorouracil and Leucovorin (sLV5FU2) as salvage-line therapy in metastatic colorectal cancer patients who have been either refractory to or intolerant of prior all approved standard chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival
Overall survival in patients with or without KRAS mutations.
Progression-free survival in patients with or without KRAS mutations.
Progression-free survival in patients with or without metastasectomy
Response rate
Disease control rate
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
High-dose Bevacizumab + sLV5FU2
Bevacizumab 10mg/kg (d.i.v)
l-LV 200mg/m2 (d.i.v)
5-FU 400mg/m2 (b.i.v)
5-FU 2400mg/m2 (c.i.v)
Every 2weeks
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) Histological confirmation of colorectal cancer.
(2) Metastatic colorectal cancer patients with KRAS mutations who have been either refractory to or intolerant of prior Oxaliplatin , Irinotecan, Bevacizumab therapies
(3) Metastatic colorectal cancer patients without KRAS mutations who have been either refractory to or intolerant of prior
Oxaliplatin , Irinotecan , Bevacizumab , anti EGFR therapies
(4) 20 years old or more when received informed consent.
(5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) : 0 - 1.
(6) With estimative lesion observed in imaging (measurable lesions in RECIST criteria [ver.1.1] )
(7) Life expectancy estimated 3 months, and more.
(8) Vital organ functions (listed below) are preserved within 14 days prior to entry.
Neutrophil count >=1500/mm3 and =<12,000/mm3)
Platelets >=75,000/mm3
Hemoglobin >=8.0g/dl
Total bilirubin <=2.0g/dl
AST and ALT <=100IU/l
(<=200IU/l in case of liver metastasis)
Serum creatinine < upper limit of normal (ULN) *1.5
Urinary protein <=grade1 (+1)
(9) Written informed consent.
Key exclusion criteria
(1) Hypersensitivity or history of the severe hypersensitivity for Bevacizumab, Fluorouracil and Leucovorin.
(2) Prior abdominal non-local irradiation for colorectal cancer.
(3) Complication of cerebrovascular disease or its symptoms within 1 year.
(4) With sever complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, hypertension, cardiac failure, renal failure, liver dysfunction, and so on).
(5) With complication of history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
(6) Massive pleural or ascites that required drainage.
(7) Uncontrolled Hypertension.
(8) Uncontrolled peptic ulcer.
(9) Uncontrolled diarrhea.
(10) Uncontrolled infection.
(11)Diathesis of bleeding (history of hemoptysis, including cavitation and / or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor.
(12) Patient With colonic stent.
(13) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low-dose of aspirin.)
(14) Active multiple primary cancer.
(15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(16) With mental disorder or psychological symptoms which disturb registration to this study.
(17) Not appropriate for the study at the physician's assessment.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
The University of Tokyo,
Graduate School of Medicine
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
kokudo-2su@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Oba |
Organization
The University of Tokyo, Graduate School of Medicine
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3353-2681
Homepage URL
noble-office@umin.org
Sponsor or person
Institute
The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
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
日本赤十字社医療センター(東京都)、江戸川病院(東京都)、KKR札幌医療センター(北海道)、聖隷三方原病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | 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 | 01 | Month | 18 | Day |
Last modified on
| 2015 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011480
