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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034857
Receipt No. 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

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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
Email 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
Email taksasak@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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039745

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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