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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013000
Receipt No. R000015018
Scientific Title Phase II study of perioperative chemotherapy (preoperative XELOX+Bevacizumab/ postoperative XELOX) in patients with locally advanced rectal cancer
Date of disclosure of the study information 2014/01/28
Last modified on 2015/02/02

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Basic information
Public title Phase II study of perioperative chemotherapy (preoperative XELOX+Bevacizumab/ postoperative XELOX) in patients with locally advanced rectal cancer
Acronym pedioperative chemotherapy study of XELOX +bevacizumab for locally advanced rectal cancer.(RUDDER Trial)
Scientific Title Phase II study of perioperative chemotherapy (preoperative XELOX+Bevacizumab/ postoperative XELOX) in patients with locally advanced rectal cancer
Scientific Title:Acronym pedioperative chemotherapy study of XELOX +bevacizumab for locally advanced rectal cancer.(RUDDER Trial)
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of preoperative XELOX + bevacizumab and postoperative XELOX in patients with locally advanced rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Treatment completion rate
Key secondary outcomes safety(perioperative complications, adverse events by chemotherapy), 3-year recrence free survival rate, 3-year local recurrence-free survival rate, 3-year overall survival rate, R0 resection rate, pathological effect, relative dose intensity, overall response rate, down- staging rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After 4cycle of preoperative XELOX+Bevacizumab(BV(-)at 4th cycle),primary resection is to be perfomed.Primary resection have to be done with in 4-8 weeks after last dose of Capecitabine.After resection,4cycles of postoperative XELOX to be administered.
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.Written informd consent
2.Rectal cancer with inferir edge located below peritoneal reflection,histologically adeno
3..cT2 N1,cT3 N0-1
4.20-80 years old
5.ECOG PS0-1
6.Life expect ancy from the day of eneollment is 3 months or longer
7.No prior radiotherapy
8.Major organ functions less than 14 days prior to entty meet the following criteria
(Neutrophil count>=1500/mm3,Platelet count>=100.000/mm3,Hb>=9.0dl,T-Bil<=2.0mg/dl,AST ALT<=100U/L,Cre Men <1.8mg/dl female<1.35mg/d)
Key exclusion criteria 1. Need to drain malignant coelomic fluid;
2.Multiple primary cancer within 5years
3. Bleeding tendency, coagulation factor or abnormal clotting disorder (INR 1.5)
4. Intestinal paralysis, intestinal obstruction, peptic ulcer uncontrollable
5.Serious complications (diabetes, infections, diarrhea)
6. Symptomatic or asymptomatic but treated heart disease. History of those within one year prior to enrollment
7. History of the serious hypersensitivity for fluorouracil, platinum compound. History of adverse events related to DPD loss
8. Peripheral sensory neuropathy (CTCAE v4.0 Grade 1);
9.Pulmonary fibrosis or interstitial pneumonia
10. Current or previous (within the last 1 year) history of cerebrovascular disease
11.Administered antithrombotic agents for thrombosis within 10 days prior to enrollment
12. Serious hypertension
13. History of gastrointestinal perforation
14.Pregnant women,possibly pregnant women, wishing to become pregnant, and nursing mothers;
15.No intention to practice birth control;
16.Previously treated with oxaliplatin;or capecitabine
17.Any other medical conditions disable to comply with the protocol
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Kotaka, MD
Organization Sano Hospital
Division name Gastrointestinal Cancer Center
Zip code
Address 2-5-1 Shimizugaoka,Tarumi-ku,Kobe, Hyogo,Japan
TEL 078-785-1000
Email tomomakotaka6410@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Kotaka, MD
Organization Sano Hospital
Division name Gastrointestinal Cancer Center
Zip code
Address 2-5-1 Shimizugaoka,Tarumi-ku,Kobe, Hyogo,Japan
TEL 078-785-1000
Homepage URL
Email tomomakotaka6410@yahoo.co.jp

Sponsor
Institute Sano Hospital Masahito Kotaka, MD
Institute
Department

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
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
2014 Year 01 Month 28 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
2013 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 06 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 01 Month 28 Day
Last modified on
2015 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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