UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003500 |
|---|---|
| Receipt number | R000004243 |
| Scientific Title | Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer |
| Date of disclosure of the study information | 2010/04/16 |
| Last modified on | 2018/09/20 08:22:01 |
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Basic information
Public title
Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer
Acronym
ASCA study
Scientific Title
Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer
Scientific Title:Acronym
ASCA study
Region
| Japan |
Condition
Condition
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 the combination of XELOX with Bevacizumab in the super elderly patients with unresectable advanced/recurrent colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Toxicity
ORR; overall response rate
TTF; time to treatment failure
OS; overall survival
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
XELOX+BV regimen (Capecitabine, Oxaliplatin, Bevacizumab)
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)All patients provided written informed consent before initiation of study-related procedures.
2)over 75 years old at the informed consent.
3)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4)A life expectancy of more than 3 months.
5)Histologically confirmed colorectal cancer.
6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1. (however, the patients with two or more and 5 mm or more lung metastasis is eligible)
7)No prior chemotherapy or first recurrence with no chemotherapy for recurrent lesion.(without receiving adjuvant chemotherapy by 5FU only)
8)Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration:
i.White blood cell count over 3000/mm3.
ii.Neutrocyte count over 1500/mm3.
iii.Platelet count over 100 000/mm3.
iv.Hemoglobin over 9.0 g/dl
v.Total bilirubin level, 1.5
times the institutional upper
limit of normal.
vi.Aspartate aminotransferase and
alanine aminotransferase
levels, 2.5 times the
institutional upper limit of normal.
vii.Serum creatinine level below
the institutional upper limit
of normal or over 50 ml/min.
Key exclusion criteria
1)Uncontrolled pleural effusion or ascites.
2)Brain metastasis.
3)Other active malignancies or a history of other malignancies within the past 5 years.
4)Clinically problematic cerebrovascular disease or arterial thromboembolism, or history of cerebrovascular disease or arterial thromboembolism within the past 1 year.
5)Surgery, biopsy specimen with section or sutures within the past 4 weeks. Fine needle aspiration biopsy within 1 week.
6)Planning of surgery during the trial.
7)Clotting drug use within the past 10 days.
8)Bleeding tendency.
9)Uncontrolled peptic ulcer.
10)Perforation of the digestive tract or history of the perforation of the digestive tract within the past 6 months.
11)Untreated traumatic bone fracture.
12)Nephropathy that requires medication or transfusion or urine protein over +2 within 2 weeks examination.
13)Uncontrolled hypertension.
14)Uncontrolled diabetes mellitus.
15)Clinically problematic cardiac disease (grade 2 or more, based on Common Toxicity
Criteria for Adverse Events [CTCAE] ver.4.0 within the past 12 months).
16)History of hypersensitivity against fluorouracil or platinum agents.
17)History of the adverse events related to dihydropyrimidine dehydrogenase deficiency against fluorinated pyrimidines.
18)Uncontrolled diarrhea.
19)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.).
20)Organ transplant that requires any immunosuppressant.
21)Uncontrolled infection.
22)History of bevacizumab use.
23)Unable to intake orally.
24)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Matsuoka |
Organization
Matsuoka clinic
Division name
Internal Medicine
Zip code
Address
2-9-15, Oji, Kitakatsuragi, Nara
TEL
0745-33-1500
masa2722@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tosio Otuji |
Organization
Dongo Hospital Kenseikai
Division name
Internal Medicine
Zip code
Address
12-3 Hinodecho, Yamatotakada, Nara
TEL
0745-53-5471
Homepage URL
hxgcd792@yahoo.co.jp
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2010 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | 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
| 2010 | Year | 04 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004243
