UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001161 |
|---|---|
| Receipt number | R000001416 |
| Scientific Title | Phase 2 trial of sphincter-preserving operation for low rectal cancer |
| Date of disclosure of the study information | 2008/05/26 |
| Last modified on | 2010/11/22 11:02:56 |
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Basic information
Public title
Phase 2 trial of sphincter-preserving operation for low rectal cancer
Acronym
Clinical trial for sphincter preserving
Scientific Title
Phase 2 trial of sphincter-preserving operation for low rectal cancer
Scientific Title:Acronym
Clinical trial for sphincter preserving
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 enaluate whether intersphincteric resection was safe and curative for low rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Rate of a successful therapy
Mortality rate
Three-year local recurrence rate
Key secondary outcomes
Morbidity rate
Anal function
Three-year disease free survival
Rate of patients who avoided permanent stoma
Evaluation of QOL
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
| Maneuver |
Interventions/Control_1
Performance of anus-preserving operation for patients with low 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
| Not applicable |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Tumors were located below 5cm from anal verge or below 3cm from dentate line.
2. Adenocarcinoma was pathologically proven.
3. T1-T3
4. M0
5. Systemic status which allow the operation.
6. < 76 years old
7. Performance status was 0 or 1.
8. Informed consent was given.
Key exclusion criteria
1. Patients who prefer a standard operation, abdomino-perineal resection.
2. Tumors which were suspected of scirrous invasions.
3. Patients who underwent preoperative therapies such as chemotherapy, radiation, or immunotherapy.
4. Severe anal dysfunction
5. Double cancers.
6. Severe complications such as diabetes, hypertension or pulmonary fibrosis.
7. Patients who have psychogenic disease.
8. Informed consent was not given.
9. Not judged as eligible by doctors.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Saito |
Organization
National Cancer Center Hospital East
Division name
Department of colorectal and pelvic surgery
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471-33-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Ito |
Organization
National Cancer Center Hospital East
Division name
Department of colorectal and pelvic surgery
Zip code
Address
TEL
Homepage URL
norsaito@east.ncc.go.jp
Sponsor or person
Institute
ISR study group
Institute
Department
Personal name
Funding Source
Organization
This study was supported in part by a Grant-in-Aid for Cancer Research from the Ministry of Health and Welfare and Labor of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 05 | Month | 26 | 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
| 2005 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 05 | Month | 20 | Day |
Last modified on
| 2010 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001416
