UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009719 |
|---|---|
| Receipt number | R000011393 |
| Scientific Title | Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801) |
| Date of disclosure of the study information | 2013/01/08 |
| Last modified on | 2013/01/07 19:19:32 |
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Basic information
Public title
Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)
Acronym
Carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)
Scientific Title
Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)
Scientific Title:Acronym
Carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)
Region
| Japan |
Condition
Condition
Post-operative pelvic recurrence of rectal cancer
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of 16 fractionated carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Local control rate at 3 years
Key secondary outcomes
Response rate, progression-free survival rate, overall survival rate, acute complication rate, late complication rate, QOL
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologiccally or clinically diagnosed post-operative pelvic recurrence of primary rectal cancer
2)Intra-pelvic local recurrence without extra-pelvic recurrence
3)Currative resected primary tumor 4)Measureable tumor
5)Past history of chemotherapy over 4 weeks before treatment
6)Age between 20 and 80 years old
7)PS 0-3
8)Adequate organ functions
9)Informed consent
Key exclusion criteria
1)Tumors if applicable following conditions ; a)Obvious bladder invasion, b)Anastomotic recurrence.
2)Obivious tumor invasion to bowels
3)Past history of irradiation to the target
4)Open wound or uncontrolled infectious disease
5)Uncontrolled severe complication 6)Active double cancers
7)In pregnancy or during the lactation preiod
8)Other medical or psychological unsuitable reasons
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy-ion Medical Center
Zip code
Address
3-39-22, Showa, Maebashi, Gunma 371-8511
TEL
027-220-8378
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohno |
Organization
Gunma University
Division name
Gunma University Heavy-ion Medical Center
Zip code
Address
3-39-22, Showa, Maebashi, Gunma 371-8511
TEL
027-220-8378
Homepage URL
Sponsor or person
Institute
Gunma University Heavy-ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
群馬大学重粒子線医学研究センター（群馬県）Gunma University Heavy-ion Medical Center
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 08 | 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
| 2009 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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 study
Management information
Registered date
| 2013 | Year | 01 | Month | 07 | Day |
Last modified on
| 2013 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011393
