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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011417
Receipt No. R000013367
Scientific Title Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer
Date of disclosure of the study information 2013/08/15
Last modified on 2013/08/08

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Basic information
Public title Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer
Acronym T1, T2 Study
Scientific Title Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer
Scientific Title:Acronym T1, T2 Study
Region
Japan

Condition
Condition T1,T2 cancer of low rectum
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation on feasibility of local excision with chemoradiotherapy for T1,T2 lower rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease free survival at five years
Key secondary outcomes Overall survival at five years
Local relapse-free survival
Salvage treatment and prognosis
Adverse events in chemoradiotherapy

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 Maneuver Other
Interventions/Control_1 Local excision
Postoperative chemoradiotherapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Primary rectal cancer located within lower rectum
2. Clinical T1 or T2, N0, M0
3. Tumor size within 3cm, and possible to be curative local excision
4. Without severe complications. PS(ECOG) of 0 or 1
5. Pathological proven well or moderately adenocarcinoma
6. First treatment of rectal cancer
7. Without synchronous or metachronous ( within 5 years ) malignancies
8. written informed consent
9. Aged 20 to 75 years old.
Pathological proven well or moderately adenocarcinoma in resected specimen
10. Depth of sm-massive invasion, or with lymphatic or venous vessels invasion, or depth of mp invasion
11. Pathological negative surgical margins in resected specimen
12. Enough organ functions
i. WBC count : >=3000/mm3
ii. Platelet count : >=100,000/mm3
iii. T-Bil : <=1.5mg/dl
iv. AST/ALT : <=100IU/l
v. Cr : <=1.5mg/dl
Normal ECG
Key exclusion criteria 1. Pathological proven poorly or mucinous adenocarcinoma by biopsy
2. Clinical N positive
3. Distant metastasis
4. PS (ECOG) 2, 3, and 4
5. Without written informed consent
6. Pathological proven poorly or mucinous adenocarcinoma in resected specimen
7. Pathological positive surgical margins in resected specimen
8. Depth of m invasion, or sm-minute invasion without vessels invasion
9. Bone marrow dysfunction
10. Be certain or suspicious pregnant
11. Precious radiotherapy in abdomino-pelvic area
12. Unsuitable patients for this study
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Saito
Organization National Cancer Center Hospital East
Division name Colorectal and Pelvic Surgery
Zip code
Address 6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
TEL 04-7133-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norio Saito
Organization National Cancer Center Hospital East
Division name Colorectal and Pelvic Surgery
Zip code
Address 6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email norsaito@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
愛知県がんセンター中央病院(愛知県)
山形県立中央病院(山形県)
大阪府立成人病センター(大阪府)
新潟県立がんセンター(新潟県)
石川県立中央病院(石川県)
四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
国立病院機構名古屋医療センター(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 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 No longer recruiting
Date of protocol fixation
2002 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2002 Year 12 Month 01 Day
Last follow-up date
2015 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013367

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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