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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name