UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032534 |
|---|---|
| Receipt number | 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 | 2020/05/10 09:46:17 |
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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 | Ikeda |
| Middle name | |
| Last name | Masataka |
Organization
Hyogo College of Medicine
Division name
Division of Lower GI Surgery, Department of Surgery
Zip code
663-8501
Address
1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6372
ms-ikeda@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kimura |
| Middle name | |
| Last name | Kei |
Organization
Hyogo College of Medicine
Division name
Division of Lower GI Surgery, Department of Surgery
Zip code
663-8501
Address
1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6372
Homepage URL
k-kimura@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
Hyogo College of Medicine
Address
1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6372
k-kimura@hyo-med.ac.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
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
| 2020 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037010
