UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004556 |
|---|---|
| Receipt number | R000005442 |
| Scientific Title | Pilot Study of chemotherapy with Capecitabine,Oxaliplatin and Bevacizumab for pulmonary metastases from colorectal cancer |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2019/05/23 09:38:17 |
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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
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
noura-si@mc.pref.osaka.jp
Public contact
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
noura-si@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005442
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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