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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name