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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032534
Receipt No. R000037010
Scientific Title Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer
Date of disclosure of the study information 2018/05/09
Last modified on 2018/05/09

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Basic information
Public title Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer
Acronym Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer
Scientific Title Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer
Scientific Title:Acronym Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer
Region
Japan

Condition
Condition Resectable local pelvic recurrence of rectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficiency and safety of neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic radical surgery for locally recurrent rectal malignant tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Safety (operative time, intraoperative bleeding, conversion to open surgery, incidence of complication after surgery, hospitalized days after surgery
Key secondary outcomes R0 resection rate
TRG: tumor regression grade
pCRM: pathological circumferential resection margin
QOL: quality of life after surgery
OS: overall survival
RFS: recurrence free survival
LFS: local recurrence free survival,

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 Neoadjuvant chemoradiothearpy with capecitabine followed by laparoscopic surgery
Capecitabine; treatment dose was decided by body mass index
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: R0 resection was performed by the initial surgery for rectal malignant tumor
2: The diagnosis of recurrent rectal cancer was proven with tissue biopsy, or with medical imaging.
3: The recurrent tumor should be localized without extra-pelvic metastasis, distant metastasis was absent.
4: Patients had to have ECOG performance status of 0 or 1.
5: Written informed consent was obtained from all patients before enrollment.
Key exclusion criteria 1: Unresectable: tumor extension into S1 nerve, external iliac artery,obturator internus muscle
2: Patients with serious complications
3: Patients who would not complete this study according to surgeon's decision
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Ikeda
Organization Hyogo College of Medicine
Division name Division of Lower GI Surgery, Department of Surgery
Zip code
Address 1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6372
Email ms-ikeda@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Kimura
Organization Hyogo College of Medicine
Division name Division of Lower GI Surgery, Department of Surgery
Zip code
Address 1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6372
Homepage URL
Email k-kimura@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
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 05 Month 09 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 09 Day
Last follow-up date
2023 Year 05 Month 31 Day
Date of closure to data entry
2023 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2018 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037010

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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