UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018994 |
|---|---|
| Receipt number | R000021949 |
| Scientific Title | Prospective Observational Study of LAParoscopic Pelvic Exenteration or Laparoscopic Surgery with Bony Pelvic Resection for Primary Advanced or Locally Recurrent Colorectal Malignancy |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/01/18 10:11:58 |
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Basic information
Public title
Prospective Observational Study of LAParoscopic Pelvic Exenteration or Laparoscopic Surgery with Bony Pelvic Resection for Primary Advanced or Locally Recurrent Colorectal Malignancy
Acronym
LAP-PE STUDY
Scientific Title
Prospective Observational Study of LAParoscopic Pelvic Exenteration or Laparoscopic Surgery with Bony Pelvic Resection for Primary Advanced or Locally Recurrent Colorectal Malignancy
Scientific Title:Acronym
LAP-PE STUDY
Region
| Japan |
Condition
Condition
Primary advanced or locally recurrent colorectal malignancy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficany and safety of laparoscopic pelvic exenteration or laparoscopic surgery with bony pelvic resection
for primary advanced or locally recurrent colorectal malignancy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local R0 resection rate
Key secondary outcomes
Safety (incidence of adverse events, intra- and post-operative complications), Local recurrence rate, Disease-free survival (DFS), Overall survival (OS)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histological confirmation of colorectal malignancy.
2. Total pelvic exenteration, anterior pelvic exenteration, posterio pelvic exenteration, or bony pelvic resection are necessary.
3. Age: 20-years old.
4. Radical resection for local tumor is possible. Radicality of distant metastasis is not necessary.
5. Written informed consent.
Key exclusion criteria
1. Open surgery.
2. Radical resection is possible by partial resection of bladder, prostate, or vagina.
3. Not suitable for this study for medical reasons.
4. No written informed consent.
5. Other conditions not suitable for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsugu Sekimoto |
Organization
National Hospital Organization, Osaka National Hospital
Division name
Department of Surgery
Zip code
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka
TEL
+81-6-6942-1331
onh.seki@onh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Akiyoshi |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
+81-3-3520-0111
Homepage URL
takashi.akiyoshi@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
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
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
国立病院機構大阪医療センター(大阪府）、がん研有明病院（東京都）、名古屋大学病院（愛知県）、虎の門病院（東京都）、国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021949
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
