UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009719
Receipt No. R000011393
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)
Title of the study (Brief title) 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 Takashi Nakano
Organization Gunma University
Division name Gunma University Heavy-ion Medical Center
Address 3-39-22, Showa, Maebashi, Gunma 371-8511
TEL 027-220-8378
Email

Public contact
Name of contact person Tatsuya Ohno
Organization Gunma University
Division name Gunma University Heavy-ion Medical Center
Address 3-39-22, Showa, Maebashi, Gunma 371-8511
TEL 027-220-8378
Homepage URL
Email

Sponsor
Institute Gunma University Heavy-ion Medical Center
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2009 Year 09 Month 02 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011393

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form