UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017579
Receipt number R000020371
Scientific Title A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness
Date of disclosure of the study information 2015/05/15
Last modified on 2023/05/23 16:48:06

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Basic information

Public title

A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness

Acronym

A phase I/II study of proton beam therapy for early breast cancer

Scientific Title

A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness

Scientific Title:Acronym

A phase I/II study of proton beam therapy for early breast cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To find optimal dose and to evaluate safety and effectiveness of proton beam therapy for stage I breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Adverse events of normal tissue

Key secondary outcomes

location of local recurrence, duration of extra-breast recurrence, survival duration, cosmesis


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

Maneuver

Interventions/Control_1

Proton beam therapy 62.4 GyE/26 fractions

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

40 years-old <=

Age-upper limit

70 years-old >=

Gender

Female

Key inclusion criteria

1) UICC-TNM classification stage I (equal or less than 1.5 cm in diameter) breast cancer.
2) Mammographicaly visible tumor without calcification.
3) Pathologically invasive ductal carcinoma.
4) No massive lymphovascular invasion.
5) Estrogen receptor positive, favor of HER2 negative.
6) Age 40-70 years old.
7) Hight </= 175 cm, body weight </= 70 kg.
8) Favor of distance to skin or rib >/= 1 cm.
9) Negative lymph node metastasis by sentinel lymph node sampling.
10) No distant metastasis.
11) Performance status 0-1.
12) Written informed consent.
13) Phase I is clinical trial.
14) Phase II is cost burden.
15) Salvage surgery will be required if recurrence is observed.

Key exclusion criteria

1) History of previous radiotherapy to the breast.
2) History of previous surgery/chemotherapy to the breast.
3) DCIS/LCIS
4) Massive intra-ductal spread.
5) Having infectious disease.
6) Having collagen disease or infectios skin disease.
7) Diabetes.
8) Pregnancy.
9) Other malignant disease.
10) Medically, psycholgicaliy or other reason who are not suitable for candidate by the physician.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Ogino

Organization

Medipolis Proton Therapy and Research Center

Division name

Proton Radiation Oncology Division

Zip code

891-0304

Address

4423 Higashikata, Ibusuki city, Kagoshima Prefecture, 891-0304 Japan

TEL

0993-23-5188

Email

mptrc@medipolis.org


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Arimura

Organization

Medipolis Proton Therapy and Research Center

Division name

Proton Radiation Oncology Division

Zip code

891-0304

Address

4423 Higashikata, Ibusuki city, Kagoshima Prefecture, 891-0304 Japan

TEL

0993-23-5188

Homepage URL

http://www.medipolis.org

Email

mptrc-ask@medipolis.org


Sponsor or person

Institute

Medipolis Proton Therapy and Research Center

Institute

Department

Personal name



Funding Source

Organization

Medipolis Proton Therapy and Research Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medipolis proton therapy and research center

Address

4423 Higashikata Ibusuki Kagoshima

Tel

0993-23-5188

Email

mptrc-ask@mediporis.org


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

メディポリス国際陽子線治療センター


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 15 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

2015 Year 05 Month 11 Day

Date of IRB

2015 Year 03 Month 20 Day

Anticipated trial start date

2015 Year 05 Month 15 Day

Last follow-up date

2031 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

2015 Year 05 Month 15 Day

Last modified on

2023 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020371


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name