UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer
Title of the study (Brief title)	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	Masaki Matsuoka
Organization	Matsuoka clinic
Division name	Internal Medicine
Address	2-9-15, Oji, Kitakatsuragi, Nara
TEL	0745-33-1500
Email	masa2722@mac.com

Public contact
Name of contact person	Tosio Otuji
Organization	Dongo Hospital Kenseikai
Division name	Internal Medicine
Address	12-3 Hinodecho, Yamatotakada, Nara
TEL	0745-53-5471
Homepage URL
Email	hxgcd792@yahoo.co.jp

Sponsor
Institute	Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004243