UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032911
Receipt number R000037461
Scientific Title A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer
Date of disclosure of the study information 2018/06/07
Last modified on 2018/06/07 18:35:34

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Basic information

Public title

A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer

Acronym

Dose escalation study of Carbon Ion Radiotherapy for CLM

Scientific Title

A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer

Scientific Title:Acronym

Dose escalation study of Carbon Ion Radiotherapy for CLM

Region

Japan


Condition

Condition

Colon cancer liver metastasis

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to identify the optimal dose of single fraction carbon-ion radiotherapy (CIRT) for colorectal cancer liver metastasis.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acute toxicity and initial tumor response

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

expanded access

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Prescribed heavy-ion beam (carbon-ion beam) dose.
Initial dose 36Gy(RBE). Dose escalated until dose limiting toxicity is met.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

This study included patients who:
1. has colorectal cancer liver metastasis diagnosed by radiological and clinical findings
2. with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
3. had primary colorectal lesions and lymph node metastasis removed totally by surgery (R0 resection) at least 4 weeks prior to enrollment and primary lesions to be histologically proven as CRC
4. have not received chemotherapy for at least 4 weeks prior to enrollment.

Key exclusion criteria

This study excluded patients who:
1. has evident vascular invasion.
2. had prior treatment to the specific lesion,
3. with lesions close to the intestine (less than 5 mm),
4. with uncontrollable ascites,
5. with severe liver damage,
6. with active coexisting malignancy,
7. with extra-hepatic lesions including local recurrence
8. were pregnant.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaru Miyazaki

Organization

Chiba University Graduate School of Medicine

Division name

General surgery

Zip code


Address

1-8-1 Inohana Chuo-ku Chiba City

TEL

043-222-7171

Email

masaru@iuhw.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirokazu Makishima

Organization

National Institutes for Quantum and Radiological Sciences and Technology

Division name

National Institutes of Radiological Sciences

Zip code


Address

4-9-1 Anagawa Inage-ku, Chiba City

TEL

043-206-3306

Homepage URL


Email

makishima.hirokazu@qst.go.jp


Sponsor or person

Institute

National Institutes for Quantum and Radiological Sciences and Technology

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 07 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

Completed

Date of protocol fixation

2006 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2006 Year 04 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



Management information

Registered date

2018 Year 06 Month 07 Day

Last modified on

2018 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name