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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016785
Receipt No. R000019479
Scientific Title Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection
Date of disclosure of the study information 2015/03/12
Last modified on 2019/09/13

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Basic information
Public title Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection
Acronym Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer
Scientific Title Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection
Scientific Title:Acronym Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate feasibility of adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of treatment completion
Key secondary outcomes

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
Interventions/Control_1 adjuvant 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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Rectal cancer
2) Local resection is performed within 12 weeks before registration day.
3) En bloc resection and margins negative
4) Histopathologically, the lesion is pSM cancer and it satisfies any one or more of the following conditions.
1. poorly differentiated adenocarcinoma
2. depth of submucosal invasion more than 1mm
3. lymphovascular invasion positive
4. budding Grade 2,3
5) No lymph node metastases and distant metastasis in diagnostic imaging within 16 weeks before registration
6) Rejection of the surgery
7) ECOG Performance Status PS:0,1
8) No history of the chemotherapy and radiotherapy
10) Blood data
1. WBC>3000/mm3
2. Hb>9.0g/dL
3. Plt>100,000/mm3
4. AST,ALT<100 IU/L
5. t-bil<2.0mg/dL
6. Cr<1.5mg/dL
11) Agreement from the patients
Key exclusion criteria 1)Presence of synchronous or metachronous advanced colorectal cancer and malignant diseases in any other
organs
2)Pregnant woman
3)Patients with psychosis
4)Use of the phenytoin and warfarin potassium
5)Use of steroids
6)Activity of hepatitis B or hepatitis C
7)Systemic infection
8)Others
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ikematsu
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology & Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email hikemats@east.ncc.go.jp

Public contact
Name of contact person
1st name Masaaki
Middle name
Last name Noguchi
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology & Gastrointestinal Oncology
Zip code 277-0871
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email manoguch@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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email irst@ml.res.ncc.go.jp

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 愛知県がんセンター中央病院(愛知県)、石川県立中央病院(石川県)、京都大学病院(京都府)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、新潟県立がんセンター新潟病院(新潟県)、山形県立中央病院(山形県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 12 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 29
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
2015 Year 03 Month 02 Day
Date of IRB
2015 Year 03 Month 03 Day
Anticipated trial start date
2015 Year 03 Month 11 Day
Last follow-up date
2019 Year 03 Month 13 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 02 Month 26 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2019 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/02/26 直腸CRTのfeasibility試験:UMIN固定用190225PW.XLSX


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