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Recruitment status Suspended
Unique ID issued by UMIN UMIN000017579
Receipt No. R000020371
Official scientific title of the study 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 2016/05/18

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Basic information
Official scientific title of the study A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Yoshio Hisikawa
Organization Medipolis Proton Therapy and Research Center
Division name Proton Radiation Oncology Division
Address 5188 Higashikata, Ibusuki city, Kagoshima Prefecture, 891-0304 Japan
TEL 0993-23-5188
Email mptrc@medipolis.org

Public contact
Name of contact person Takeshi Arimura
Organization Medipolis Proton Therapy and Research Center
Division name Proton Radiation Oncology Division
Address 5188 Higashikata, Ibusuki city, Kagoshima Prefecture, 891-0304 Japan
TEL 0993-23-5188
Homepage URL http://www.medipolis.org
Email mptrc-ask@medipolis.org

Sponsor
Institute Medipolis Proton Therapy and Research Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Suspended
Date of protocol fixation
2015 Year 05 Month 11 Day
Anticipated trial start date
2015 Year 05 Month 15 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

Management information
Registered date
2015 Year 05 Month 15 Day
Last modified on
2016 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020371


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