UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011417 |
|---|---|
| Receipt number | 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 10:57:56 |
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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
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
norsaito@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013367
