UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034857 |
|---|---|
| Receipt number | R000039745 |
| Scientific Title | Evaluation of semi-standard treatment for lower and early-staged rectal cancer (high-risk pT1, low-risk pT2) in the late elderly patients: a multicenter prospective observational study. |
| Date of disclosure of the study information | 2018/11/20 |
| Last modified on | 2019/05/22 16:06:19 |
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Basic information
Public title
Evaluation of semi-standard treatment for lower and early-staged rectal cancer (high-risk pT1, low-risk pT2) in the late elderly patients: a multicenter prospective observational study.
Acronym
Prospective observational study for lower and early-staged rectal cancer in the late elderly patients
Scientific Title
Evaluation of semi-standard treatment for lower and early-staged rectal cancer (high-risk pT1, low-risk pT2) in the late elderly patients: a multicenter prospective observational study.
Scientific Title:Acronym
Prospective observational study for lower and early-staged rectal cancer in the late elderly patients
Region
| Japan |
Condition
Condition
Lower rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and validity of semi-standard therapy without additional radical surgery for lower and early-staged rectal cancer after margin-negative local excision and diagnosed as high-risk pT1 or low-risk pT2 cancer in late elderly patients (aged 75 or older).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
2-year non-deteriorating rate of quality of life (Wexner score, Low anterior resection syndrome (LARS) score, Proportion of anus-preservation without stoma at 2 year)
Key secondary outcomes
Deteriorating rate of the degree of living independence for the elderly patients with/without dementia(2-year), scoring of Mini-cog scale(2 year), complication of the treatment (2 year), overall survival (5 year), relapse free survival (5 year), rate of occuring other disieases (5 year)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age at registration is 75 and over.
2) Primary tumor located at lower rectum, and the lower border of the primary tumor located at anal side of middle Houston valve by endoscopic finding before local resection.
3) Within 16 weeks after local resection.
4) Complete resection (en bloc) was performed by local resection and pathologically diagnosed as HM0 and VM0 (= PM0, DM0, RM0)
5) Pathological T1 cancer with fulfilled either of the following condition.
i) Poorly differentiated adenocarcinoma (por), or mucinous adenocarcinoma (muc), or signet-ring cell carciona (sig), ii) Pathological T1b, iii) Lymphatic invasion positive or venous invasion positive, iv) Budding grade of 2-3
or pathological T2 cancer with fulfilled both of the following condition.
i) well or moderately diiferentiated adenocarcinoma, ii) the greatest tumor diameter was within 3 cm.
6) Neither lymph node metastases nor distant metastases was confirmed by chest, abdomen, and pelvis computed tomography (cN0M0)
7) Witten informed consent is obtained
8) Patients who are 75 years or older who are planned radical surgery without local excision and who meet the above 2) by endoscopic diagnosis before surgery and 5) by the postoperative pathology enables registration to group A.
Key exclusion criteria
1) Patients thought to be ineligible for this study by their doctor.
2) Without written informed consent from patient or his/her family.
3) Of patients in group A registered according to eligibility criteria 8), if post-operative pathological findings prove that they do not meet eligibility criteria 5), they are excluded at that point and excluded from the final analysis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Ito |
Organization
National cancer center hospital East
Division name
Division of Colorectal Surgery
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL
04-7133-1111
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Sasaki |
Organization
National cancer center Hospital East
Division name
division of Colorectal Surgery
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL
04-7133-1111
Homepage URL
taksasak@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
Japanese Governmental office
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
| 2018 | Year | 11 | Month | 20 | 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
| 2018 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Totally 30 domestic institutions join this study.
Tohoku university, Jichi medical university, Tochigi cancer center hospital, Saitama medical university International medical center, Matsudo city general hospital, Toho university medical center Sakura hospital, Kitasato university Kitasato Institute hospital, Juntendo university, Hiratsuka city hospital, Yokohama shin-midori general hospital, Kanagawa cancer center hospital, Fujisawa city hospital, Niigata cancer center hospital, Koseiren Takaoka Hospital, Mie university, Yodogawa Christian hospital, Osaka medical university, Hiroshima city Hiroshima citizens hospital, Ehime prefectural central hospital, Sumitomo Besshi hospital, Kochi university, Nagasaki university, Ryukyu university, Urasoe General Hospital, Kyoto university, Kitano hospital, Medlical Topia Soka hospital, Shikoku cancer center hospital, Ishikawa prefectural center hospital
Management information
Registered date
| 2018 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039745
