UMIN-CTR Clinical Trial

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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