UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009748 |
|---|---|
| Receipt number | R000011421 |
| Scientific Title | Clinical Efficacy and Safety Assessment of Oxaliplatin and Fluorouraciland, Leucovorin [modified FOLFOX6] in Combination with High-dose Bevacizumab as Second-line Therapy in Patients with Advanced or Recurrent Colorectal Cancer after Failure to Irinotecan. Multicenter Clinical Study. |
| Date of disclosure of the study information | 2013/01/15 |
| Last modified on | 2013/01/10 17:12:48 |
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Basic information
Public title
Clinical Efficacy and Safety Assessment of Oxaliplatin and Fluorouraciland, Leucovorin [modified FOLFOX6] in Combination with High-dose Bevacizumab as Second-line Therapy in Patients with Advanced or Recurrent Colorectal Cancer after Failure to Irinotecan. Multicenter Clinical Study.
Acronym
High-FlierS Study
Scientific Title
Clinical Efficacy and Safety Assessment of Oxaliplatin and Fluorouraciland, Leucovorin [modified FOLFOX6] in Combination with High-dose Bevacizumab as Second-line Therapy in Patients with Advanced or Recurrent Colorectal Cancer after Failure to Irinotecan. Multicenter Clinical Study.
Scientific Title:Acronym
High-FlierS Study
Region
| Japan |
Condition
Condition
Patients with advanced or recurrent colorectal cancer after failure to Irinotecan.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of the combination of mFOLFOX6 + High-dose Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to Irinotecan and Bevacizumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival [PFS]
Key secondary outcomes
Overall survival-1[OS-1 defined as the time duration from enrollment to death due to any cause.]
The second progression-free survival (2nd PFS)[Defined as the time duration from the date of initiation of the first-line therapy to investigator-assessed disease progression or patient death due to any cause after starting the second-line treatment.]
Overall survival-2 [OS-2 defined as the time duration from the date of initiation of each therapy to death due to any cause.]
Response Rate
Disease Control RateTime 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-OHP 85 mg/m2 (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.Patients with disease progression (according to RECIST criteria),and previously treated with Bevacizumab and Irinotecan-based chemotherapy as first- line therapy.
3.Bevacizumab was continued until the disease progression except for withdrawal from Irinotecan and Bevacizumb as first-line chemotherapy due to progressive disease. (If irinotecan is discontinued due to adverse events or withdrawal, the continuation Strategy of fluoropyrimidine combination with Bevacizumab is Considered)
4.Diagnosis of progression of disease less than 2 months after last Bevacizumab administration.
5.No previous treatment with EGFR antibody therapy contained regimen.
6.Unresectable primary tumor or with one or more unresectable metastatic tumor.
7.No previous metastasectomy
8.20 years old or more when received informed consent.
9.Eastern Cooperative Oncology Group (ECOG) performance status (PS):0 - 2.
10.With estimative lesion observed in imaging or intraoperation within 28 days before registration. (measurable lesions in RECIST criteria (ver.1.1)is dispensable)
11.Withdrawal from first-line chemotherapy due to toxicity or progressive disease
12.Patients with metastatic colorectal cancer who had previously received first- line therapy with an Irinotecan-based regimen.
13.No previous treatment with Oxaliplatin contained regimen.
(Including adjuvant chemotherapy)
14.Life expectancy estimated 2 months, and more.
15.Vital organ functions (listed below) are preserved within 14 days prior to entry.
i. White blood cell count 3500/mm3>= (Neutrophils>=1500/mm3)
ii. Platelets>=100,000/mm3
iii. Total Bilirubin>=upper limit of normal (ULN)*1.5
iv. AST and ALT<=upper limit of normal (ULN)*2.5
(<=ULN*5 in case of liver metastasis)
v. Hemoglobin>=9.0 g/dl
vi. Serum creatinine<=upper limit of normal (ULN)
vii. Urinary protein >= grade1 (+1)
16.Written informed consent.
Key exclusion criteria
1.Hypersensitivity or History of the severe hypersensitivity for Bevacizumab, Fluorouraciland Leucovorin.
2.Prior abdominal irradiation for colorectal cancer.
3.CNS metastases or brain cancer confirmed by imaging (When it is suspected, imaging confirmation is required).
4.Complication of cerebrovascular disease or its symptoms within 1 year.
5.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).
6.With complication of history of Gastrointestinal perforation, Intestinal tract paralysis, or Ileus within 1 year.
7.Massive pleural or Ascites that required drainage.
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.Administrated Antithrombotic drug or drug affected to Congealing Fibrinogenolysis System within 14 days before enrollment (Except for low-dose of Aspirin.)
13.Active multiple primary cancer.
14.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
15.With mental disorder or psychological symptoms which disturb registration to this study.
16.Not appropriate for the study at the physician's assessment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
Third Department of Surgery
Zip code
Address
6-7-1,Nishishinjuku,Shinjuku-ku,Tokyo,160-0023
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Katsumata |
Organization
Tokyo Medical University
Division name
Third Department of Surgery
Zip code
Address
6-7-1,Nishishinjuku,Shinjuku-ku,Tokyo,160-0023
TEL
03-3342-6111
Homepage URL
k-katsu@tokyo-med.ac.jp
Sponsor or person
Institute
Third Department of Surgery,Tokyo Medical University
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
東京医科大学病院（東京都）
東京医科大学 八王子医療センター（東京都）
厚生中央病院（東京都）
戸田中央総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
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
| 2012 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
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 | 10 | Day |
Last modified on
| 2013 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011421
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