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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007184
Receipt No. R000008449
Scientific Title Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy
Date of disclosure of the study information 2012/03/01
Last modified on 2017/06/24

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Basic information
Public title Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy
Acronym Limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy
Scientific Title Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy
Scientific Title:Acronym Limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of combination thrapy of limited Surgery with adjuvant chemoradiotherapy for T1 or T2 lower rectal Cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Disease-free survival
Overall survival
Local relapse-free survival
Adverse events,
Anal sphincter preservation
Anal function

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 S-1 (80 mg/m2/d) was given orally after breakfast and dinner on Days 1 to 5, 8 to 12, 22 to 26, and 29 to 33.
Radiotherapy was administered in fractions of 1.8 Gy/d, given 5 days per week for 5 weeks. The total dose of radiation was 45 Gy.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Main part of the tumor is located in P-Rb.
2) Previously untreated locally advanced lower rectal cancer with preoperative diagnosis of T1/2 and N0-3 and M0.
3) Tumor diameter=< 30mm
4) Well differentiated adenocarcinoma or Moderately differentiated adenocarcinoma
5) Has at least one of the following factors
i. Invaded the submucosa (SM)>= 1000um or muscularis propria (MP).
ii. Has venous or lympho-vessel invasion
iii. Tumor budding Grade2/3
6) Negative surgical margin
7) No prior therapy expect the operation.
8) No severe complications
9) Age :> =65 years
10) Performance status (ECOG) of 0-1
11) Capability of oral intake
12) Patients who have satisfied the following the clinical test values within two weeks before the registration.
i. WBC: 3,000-12,000 /mm3
ii. Neutrophile:>= 1,500/mm3
iii. Platelet :> = 100,000/mm3
iv. Hemoglobin :> = 9.0g/dL
v. Total bilirubin: =< 2.0 mg/dL
vi. AST :=< 100IU/L
vii. ALT :=< 100IU/L
viii. Ccr: >= 40 ml/min
13) Written informed consent.
Key exclusion criteria 1)Active synchronous or metachronous malignancy carcinoma in situ.
2) Non-treated radiotherapy
3) Medical history of severe anaphylaxis or allergia to any drug.
4) Severe diarrhea.
5)Undergoing treatment with fluorocytosine.
6) Severe complication.
7) Pregnant or lactating woman at any time during study. Men of the fertility hope.
8) Severe mental disorder.
9) Patients judged inappropriate for the study by their physicians.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Noura
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Surgery
Zip code
Address 1-3-3 nakamichi, higashinari, Osaka 537-8511,Japan
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Ikeda Tsunekazu Mizushima
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
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
2012 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 02 Month 01 Day
Last modified on
2017 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008449

Research Plan
Registered date File name
2016/07/06 T1, T2下部直腸癌に対する補助療法併用縮小手術の評価第Ⅱ相臨床試験.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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