UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022731
Receipt number R000025839
Scientific Title A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation
Date of disclosure of the study information 2016/06/14
Last modified on 2023/06/21 13:45:00

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Basic information

Public title

A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation

Acronym

Carbon-ion re-irradiation for pelvic recurrent rectal cancer

Scientific Title

A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation

Scientific Title:Acronym

Carbon-ion re-irradiation for pelvic recurrent rectal cancer

Region

Japan


Condition

Condition

pelvic recurrent rectal cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to asses carbon ion radiation therapy performed as re-irradiation in patients with locally recurrent rectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3 years survival rates

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Heavy-ion particle irradaition
70.4Gy(RBE)/16fractions/4weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Confirmation of locally recurrent colorectal cancers in patients with prior carbon-ion irradiation
2. No invasion to digestive tracts, bladder or urethra
3.Not indicated for curative resection or does not wish to undergo surgery.
4.Has evaluable disease.
5.Without distant metastases by CT, MRI and PET findings
6. 20 years or older
7. Performance status between 0 and 2
8. Normal function of main organs
9.Presumed to be alive for at least 3 months.
10.Written consent to participate in this study has been obtained from the patient.

Key exclusion criteria

1. Diameter of treatment volume longer than 15cm
2.Patient receive chemotherapy within 2 weeks
3. If they have an open wound or a active inflammatory disease
4. If they have a concomitant malignancy
5. If they have a severe heart diseases, a severe cerebrovascular disorder, a severe diabetes, angina pectoris, cardiac infarction.
6.In appropriate for this clinical study because of mental disorder, or other severe concurrent disease.
7.Adults and minors who do not have the capacity to consent.

Target sample size

71


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Yamada

Organization

National Institute for Quantum and
Radiological Sciences and Technology

Division name

QST Hospital

Zip code

206-8555

Address

4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan

TEL

043-206-3306

Email

yamada.shigeru@qst.go.jp


Public contact

Name of contact person

1st name Shigeru
Middle name
Last name Yamada

Organization

National Institute for Quantum and Radiological Sciences and Technology

Division name

QST Hospital

Zip code

263-8555

Address

4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan

TEL

043-206-3306

Homepage URL


Email

yamada.shigeru@qst.go.jp


Sponsor or person

Institute

National Institute for Quantum and
Radiological Sciences and Technology
QST hospital

Institute

Department

Personal name



Funding Source

Organization

National Institute for Quantum and
Radiological Sciences 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

National Institute for Quantum and Radiological Sciences and Technology

Address

4-9-1 Anagawa, Inageku, Chiba, Japan

Tel

043-209-4706

Email

helsinki@qst.go.jp


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

2016 Year 06 Month 14 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

No longer recruiting

Date of protocol fixation

2016 Year 05 Month 16 Day

Date of IRB

2016 Year 05 Month 16 Day

Anticipated trial start date

2016 Year 06 Month 10 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 14 Day

Last modified on

2023 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name