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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name