UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013688 |
|---|---|
| Receipt number | R000015979 |
| Scientific Title | A phase II clinical trial of carbon-ion radiotherapy for patients with local recurrence after primarily resected rectal cancer (HIMAT1351) |
| Date of disclosure of the study information | 2014/04/11 |
| Last modified on | 2018/10/24 17:12:27 |
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Basic information
Public title
A phase II clinical trial of carbon-ion radiotherapy for patients with local recurrence after primarily resected rectal cancer (HIMAT1351)
Acronym
Carbon-ion radiotherapy for local recurrence after primarily resected rectal caner (HIMAT1351)
Scientific Title
A phase II clinical trial of carbon-ion radiotherapy for patients with local recurrence after primarily resected rectal cancer (HIMAT1351)
Scientific Title:Acronym
Carbon-ion radiotherapy for local recurrence after primarily resected rectal caner (HIMAT1351)
Region
| Japan |
Condition
Condition
local recurrence after primarily resected rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of carbon-ion radiotherapy for local recurrence after primarily resected rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
three year local control rate
Key secondary outcomes
response rate, survival rate, progression free survival, complication rate, pain response
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
| Other |
Interventions/Control_1
Carbon-ion radiotherapy
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) Histologically proven rectal caner
2) local recurrence after primarily resected rectal cancer
3) Recurrence after curative surgical resection (Cur A according to JSCCR Guidelines, the 7th edition)
4) No past history of irradiation to the target
5) Unresectable tumor or patient's refusal of surgery
6) Evaluable tumor
7) No distant metastasis
8) Age between 20 and 80 years old
9) PS 0-2
10) Sufficient major organ function
11) Expected to survival more than 4 months
12) Informed consent by patient
Key exclusion criteria
1) Anastomotic recurrence or invasion to bone or bladder
2) CTV over 15cm
3) CTV including gastrointestinal
4) Past history of chemotherapy within 2 weeks before treatment
5) Uncontrolled infectious disease
6) Active double cancers
7) Severe complicating disease
8) Other medical or psychological unsuitable reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
SAGA HIMAT Foundation
Division name
Ion Beam Therapy Center
Zip code
Address
3049, Harakoga-machi, Tosu, Saga, 841-0077
TEL
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Terashima |
Organization
SAGA HIMAT Foundation
Division name
Ion Beam Therapy Center
Zip code
Address
3049, Harakoga-machi, Tosu, Saga, 841-0077
TEL
0942-81-1897
Homepage URL
terashima-kotaro@saga-himat.jp
Sponsor or person
Institute
Ion Beam Therapy Center, SAGA HIMAT Foundation
Institute
Department
Personal name
Funding Source
Organization
No
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 11 | 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
| 2014 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 11 | 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
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015979
