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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012857
Receipt No. R000015025
Scientific Title A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III)
Date of disclosure of the study information 2014/01/15
Last modified on 2014/01/20

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Basic information
Public title A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III)
Acronym OITA-trial III
Scientific Title A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III)
Scientific Title:Acronym OITA-trial III
Region
Japan

Condition
Condition locally advanced rectal cancer
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether OITA-RC-Chip could predict the sensitivity of S-1+radiation as neoadjuvant chemoradiotherapy for patients with locally advanced rectal cancer
Basic objectives2 Others
Basic objectives -Others sensitivity prediction
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes predictive value of pathological response
Key secondary outcomes DFS, OS, Response rate, pathological response, Safety

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 S-1: 80 mg/m2 p.o. (day1-5, 8-12, 22-26, and 29-33)
Radiation : Total 45Gy/25fr, 1.8Gy/day, on days 1-5, 8-12, 15-19, 22-26, and 29-33).
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 confirmed rectal cancer (Ra, Rb, P)
2) Histologically confirmed adenocarcinoma
3) Within 28 days before registration, Clinical stage T3-4, N0-2(UICC 7th edition)
4) Age of 20 to 80 years old
5) PS(ECOG) 0-1
6) Previously untreated rectal cancer (including chemotherapy, radiotherapy, hormonal therapy, or surgery)
7) be able to take oral drugs
8) Required baseline laboratory parameters (within 14 days before registration):
WBC >= 3000 ,< 12000/mm3
Neu >= 1,500/mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
T-Bil <= 2.0mg/dl
AST,ALT <= 100U/L
Cre <1.5mg/dl
Ccr >= 60mL/min
9) Appropriate for the study at the physician's assessment
10) Written informed consent
Key exclusion criteria 1) History of serious drug hypersensitivity or a history of drug allergy
2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less)
3) Patients with contraindication to S-1
4) Serious complication ( ex. intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, serious diabetes, serious hypertension cardiac failure, renal failure, or liver failure)
5) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
6) Pleural effusion, peritoneal fluid that needs treatment
7) Positive for HBs antigen
8) Patients who have bleeding from GI tract, intestinal paralysis, intestinal obstruction, peptic ulcer
9) Patients who need flucytosine, phenytoin or warfarin potassium.
10) Requiring consecutive systemic administration of steroid drug
11) Pregnant or lactating woman
12) Man who hope for Partner's pregnant
13) High-grade stricture
14) Not appropriate for the study at the physician's assessment
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi INOMATA
Organization Oita University faculty of medicine
Division name Department of Gastroenterological and Pediatric Surgery
Zip code
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
TEL 097-586-5843
Email geka1@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi INOMATA
Organization Oita University faculty of medicine
Division name Department of Gastroenterological and Pediatric Surgery
Zip code
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
TEL 097-586-5843
Homepage URL
Email geka1@oita-u.ac.jp

Sponsor
Institute Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine
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 大分大学医学部消化器・小児外科学講座、大分医療センター 外科、大分県立病院 外科、大分赤十字病院 外科、健康保険南海病院 外科、中津市民病院 外科、別府医療センター 外科、九州大学病院別府病院 外科

Other administrative information
Date of disclosure of the study information
2014 Year 01 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 12 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 15 Day
Last modified on
2014 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015025

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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