UMIN-CTR Clinical Trial

Basic information
Public title	Pilot Study of chemotherapy with Capecitabine,Oxaliplatin and Bevacizumab for pulmonary metastases from colorectal cancer
Acronym	Pilot Study of chemotherapy with Capecitabine,Oxaliplatin and Bevacizumab for pulmonary metastases from colorectal cancer
Scientific Title	Pilot Study of chemotherapy with Capecitabine,Oxaliplatin and Bevacizumab for pulmonary metastases from colorectal cancer
Scientific Title:Acronym	Pilot Study of chemotherapy with Capecitabine,Oxaliplatin and Bevacizumab for pulmonary metastases from colorectal cancer
Region	Japan

Condition
Condition	Pulmonary metastases from colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of the combination of capecitabine,oxaliplatin and bevacizumab in patients with pulmonary metastases from colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	response rate,resection rate of pulmonary metastases,protcol treatment accomplish rate, progression free 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	Chemotherapy with XELOX(capecitabine+oxaliplatin)+bevacizumab Treatment repeats every 21days for up to 4courses
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histologically proven colon or rectum cancer 2.Palpable pulmonary metastases from colorectal cencer,no prior chemotherapy,surgery was done only for resect primary tumor,and passed 4weeks In case of metachronous,no prior chemotherapy to pulmonary metastases,adjuvant chemotherapy completed before more than 6months(except oxaliplatin and bevacizumab) 3.Wriiten informed consent 4.Age:20-80 years old 5.Performance status 0-1 6.A predicted life expancy of at least 3months 7.With sufficient bone marrow,renal or hepatic function WBC:>=3000/mm3(neutrocyte=>1500/mm3) Platelet:=>100,000/mm3 Hemoglobin:=>10.0g/dl Total bilirubin:=>2.0mg/dl AST(GOT):=<100IU/L ALT(GPT):=<120IU/L Serum creatinin:=<1.5mg/dl
Key exclusion criteria	1.Body cavity fluid,and it needs drainage 2.Brain metastases or brain cancer 3.With active double cancers 4.With unresectable metastases except for pulmonary metastases 5.With cerebrovascular disease,or history of cerebrovascular disease less than 1year prior to entry 6.Surgery,biopsy with skin incision,or traumatic injury with suture less than 4weeks prior to entry 7.With thrombosis,or history of thrombosis less than 1 year prior to entry 8.Trend of bleeding or coagulation disorder 9.With uncontrolable ulcer 10.With gastrointestinal perforation,or history of gastrointestinal perforation less than 1 year prior to entry 11.With bone fracture 12.With renal disfunction,or proteiun uria 2+ less than 2 weeks prior to entry 13.With uncontrolable hypertension 14.With cardiovascular disease,or myocardinal dysfunction less than 1year prior to entry 15.History of hypersensitivity for test drugs 16.History of adverse event caused by fluoropyrimidine drugs 17.With uncontrorable diarrhea 18.With interstitial pneumonia or pulmonary fibrosis 19.With uncontrorable infection 20.With carcinomatous pleuritis 21.Nursing or pregnant females,or females who are planning to pregnancy 22.Male who are plannning to pregnancy 23.Participation in other clinical trial less than 4weeks prior to entry 24.History of bevacizumab or oxaliplatin use 25.Any other serious medical consition that would preclude study treatment
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Shingo Middle name Last name Noura
Organization	Osaka International Cancer Institute
Division name	Department of surgery
Zip code	541-8567
Address	3-1-69 Otemae,Chuo-ku,Osaka 541-8567,Japan
TEL	06-6945-1181
Email	noura-si@mc.pref.osaka.jp

Public contact
1st name of contact person	1st name Yasuko Middle name Last name Nishiawa
Organization	Osaka International Cancer Institute
Division name	Department of pathology
Zip code	541-8567
Address	3-1-69 Otemae,Chuo-ku,Osaka 541-8567,Japan
TEL	06-6945-1181
Homepage URL
Email	noura-si@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
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	Osaka International Cancer Institute
Address	3-1-69 Otemae,Chuo-ku,Osaka 541-8567,Japan
Tel	06-6945-1181
Email	noura-si@mc.pref.osaka.jp

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 11 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	Enrolling by invitation
Date of protocol fixation	2010 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date	2010 Year 08 Month 01 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	2010 Year 11 Month 15 Day
Last modified on	2019 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005442