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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003701
Receipt No. R000004484
Scientific Title Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Date of disclosure of the study information 2010/06/07
Last modified on 2011/12/05

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Basic information
Public title Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Acronym Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.
Scientific Title Phase I/II trial of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Scientific Title:Acronym Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer had already been shown in western countries. The aim of this study, phase I/II trial, is to assess safety and efficacy of preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer in a Japanese population.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Side effect including clinical symptoms and blood examination.
Key secondary outcomes Efficacy
Pathologic complete response rate, pathological downstaging, sphincter preservation, survival, local recurrence, urinary disorder, and anorectal disorder.

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 Device,equipment
Interventions/Control_1 Preoperative capecitabine with concurrent radiation therapy for locally advanced rectal cancer.
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. Stage II and III respectable locally advanced rectal cancer confirmed with colonoscopy, endoscopic ultrasonography, computed tomography, and magnetic resonance imaging.
2. ECOG performance status: 0-2.
3. Age: 20-80.
4. White blood cells: 2000/mm3-15000/mm3, Platelet >7.5/mm3, GPT <150IU/L, T-bil <3.0g/dL.
5. patient providing informed consent.
Key exclusion criteria 1. Stage IV rectal cancer, rectal cancer with bowel obstruction.
2. Pregnancy.
3. Lactation.
4. Pregnancy attempy.
5. Infectious diseases.
6. Use of immunosuppressive drug and steroid.
7. Double cancer.
8. Injury and wound.
9. Paralytic ileus and interstitial pneumonia.
10. Doctor's exclusion decision.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Yamaue
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073(447)2300(5112)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shozo Yokoyama
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073(447)2300(5112)
Homepage URL
Email yokoyama@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, Second Department of Surgery
Institute
Department

Funding Source
Organization Wakayama Medical University, Second Department of Surgery
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
2010 Year 06 Month 07 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
2009 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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 06 Month 03 Day
Last modified on
2011 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004484

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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