UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021517
Receipt number R000024815
Scientific Title Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer
Date of disclosure of the study information 2016/03/18
Last modified on 2023/12/25 16:38:16

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Basic information

Public title

Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer

Acronym

Extended Study of Carbon-Ion Radiotherapy for Prostate Cancer

Scientific Title

Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer

Scientific Title:Acronym

Extended Study of Carbon-Ion Radiotherapy for Prostate Cancer

Region

Japan


Condition

Condition

Localized prostate cancer

Classification by specialty

Surgery in general Urology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of the carbon ion radiotherapy with longer hormone therapy for localized or locally advanced prostate cancer in Kanagawa Cancer Center

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Biochemical progression-free survival at 5 years

Key secondary outcomes

1) Overall survival, Disease-specific survival
2) Local recurrence-free survival
3) Early and late-phase adverse event rate


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

Device,equipment

Interventions/Control_1

Carbon-ion radiation therapy
A total of 51.6GyE consisting of 12 fractions; once a day 4.3 GyE, 6-8 times for 2 weeks

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

Key inclusion criteria

1) Histologically confirmed primary prostate adenocarcinoma
2) Clinical stage of T1b, T1c, T2a, T2b, T2c, T3a or T3b and N0 M0, in accordance with UICC 7th (2009)
3) ECOG Performance status is 0, 1 or 2
4) Twenty years or older of the age at registration
5) Untreated patient for prostate cancer, excluding neoadjuvant endocrine therapy
6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy

Key exclusion criteria

1) Patient with past history of radiotherapy for the targeted lesion
2) Patient with active double cancer
3) Patient with hormone-resistant prostate cancer
4) Patients with active and intractable infection in the targeted lesion
5) Patient with metal devices in the lesion
6) Other medical or psychological condition which is unsuitable for carbon-ion therapy

Target sample size

145


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Katoh

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Division name

Department of Carbon-ion Radiotherapy

Zip code

241-8515

Address

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture

TEL

045-520-2222

Email

hkatoh@kcch.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Katoh

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Division name

Ion-beam Radiation Oncology Center

Zip code

241-8515

Address

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture

TEL

045-520-2222

Homepage URL


Email

hkatoh@kcch.jp


Sponsor or person

Institute

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Institute

Department

Personal name



Funding Source

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Kanagawa Cancer Center IRB

Address

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture

Tel

045-520-2222

Email

clinical_trials@kcch.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

神奈川県立がんセンター(神奈川県)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 18 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

40

Results

This study confirmed safety and efficacy comparable to those reported from prior facilities.

Results date posted

2023 Year 12 Month 25 Day

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

2016 Year 03 Month 15 Day

Date of IRB

2016 Year 03 Month 15 Day

Anticipated trial start date

2016 Year 03 Month 15 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry

2028 Year 03 Month 31 Day

Date trial data considered complete

2028 Year 03 Month 31 Day

Date analysis concluded

2029 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 17 Day

Last modified on

2023 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024815


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name