UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016022 |
|---|---|
| Receipt number | R000018631 |
| Scientific Title | Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab |
| Date of disclosure of the study information | 2014/12/22 |
| Last modified on | 2019/01/30 09:03:45 |
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Basic information
Public title
Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab
Acronym
Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab
Scientific Title
Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab
Scientific Title:Acronym
Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Rate of Grade3 neuropathy
Key secondary outcomes
Response rate, Progression free survival, Overall survival, Rate of adverse events, PNQ, EORTC QLQ-C30
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+BEV
Capecitabine:2000mg/m2 d1-14
Oxaliplatin:130mg/m2 d1
Bevacizumab:7.5mg/kg d1
Q3w
Discontinuation of oxaliplatin when neurotoxicity develops >=Grade2
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Histological confirmation of adenocarcinoma.
(2)Advanced or recurrent colorectal cancer who are not candidate for curative resection.(six months after adjuvant chemotherapy is included)
(3)Presence of evaluable lesions as confi rmed by CT or MRI;no previous chemo therapy or radiotherapy
(4)Age of 70 years or older.
(5)ECOG performance status of 0-2.
(6)Adequate organ function according to following laboratory values obtained within 14 days before enrolment (Data recorded nearest to the entry should be referred. And excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
1)WBC>=3,000/mm3
2)Neu>=1,500/mm3
3)Pt>=7.5*10^4 /mm3
4)Hb>=8.0 g/dL
5)T-bil<=1.5mg/dl
6)AST and ALT <=100IU/l (Liver metastasis =< 200IU/l)
7)sCr <=Institution standard value*1.5
8)Proteinuria <=1+
(7)Written informed consent after receiving explanation of planned treatments in the study
Key exclusion criteria
(1)Complication of cerebrovascular disease or the symptoms within 1year.
(2)Invasive assessment within 4 weeks prior to enrollment in the study or aspiration biopsy cytology within 1 week.
(3)Untreated traumatic bone fracture
(4)Sever or uncontrolled complications (Peptic ulcer,hypertention,diarrhea,infections, gastrointestinal perforation,intestinal pneumonia,pulmonary fibrosis).
(5)Bleeding tendency(hemoptysis,including central necrosis/cavitation of lung metastasis)coagulopathy
(6)Receiving anticoaglant drugs within 14 days.
(7)Thrombosis,thromboembolism,or receiving anticoagulant drugs(except aspirin under 325mg/day)
(8)Cardiac disease with symptom or treatment(>=Grade2,NCI-CTCAE).Cardiac infarction within 1 year.
(9)Massive pleural effusion or peritoneal fluid
(10)History of active double cancer within 5 years.(Digestive cancer carcinoma in situ of the cervix and skin basal cell carcinoma, or by endoscopic mucosal resection endoscopic, healing has been confirmed, transition is not observed overlap cancer of less than five years was except for the prostate cancer)
(11)Neuropathy of grade 1 or more Ver.3.0 Japanese translation JCOG/JSCO version NCI-CTCAE
(12)A history of organ transplantation requiring immunosuppressive agents.
(13)Oxaliplatin, or with a history of hypersensitivity to severe capecitabine
(14)Suspected (DPD) deficiency dihydropyrimidine dehydrogenase, adverse reactions to fluoropyrimidine drugs was expressed.
(15)Active hepatitis B virus infection(HBc Ab(+) or HBV-DNA(+))
(16)Investigator deems inappropriate to participate in the test
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Endo |
Organization
Yokohama City University Hospital
Division name
gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
045-787-2800
endoit@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Ishibe |
Organization
Yokohama City University Hospital
Division name
gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
045-787-2800
Homepage URL
aishibe@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立大学附属病院（神奈川県）
横須賀共済病院（神奈川県）
横浜市立市民病院（神奈川県）
藤沢市民病院（神奈川県）
済生会横浜市南部病院（神奈川県）
独立行政法人国立病院機構横浜医療センター（神奈川県）
横浜みなと赤十字病院（神奈川県）
横浜保土ヶ谷中央病院（神奈川県）
横須賀市立市民病院（神奈川県）
伊東市民病院（神奈川県）
NTT東日本関東病院（神奈川県）
済生会若草病院（神奈川県）
横浜掖済会病院（神奈川県）
長津田厚生総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018631
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