UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021557
Receipt number R000024856
Scientific Title A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection
Date of disclosure of the study information 2016/03/24
Last modified on 2023/12/25 16:59:14

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Basic information

Public title

A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection

Acronym

Carbon-ion radiotherapy for inoperative bone and soft tissue sarcomas (iROCK-1503BS)

Scientific Title

A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection

Scientific Title:Acronym

Carbon-ion radiotherapy for inoperative bone and soft tissue sarcomas (iROCK-1503BS)

Region

Japan


Condition

Condition

Bone and soft tissue tumor

Classification by specialty

Orthopedics Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of carbon-ion radiotherapy for patients with primary bone and soft tissue sarcomas which is not suitable for surgical resection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Local control rate at 2 years

Key secondary outcomes

1) Overall survival
2) Progression free survival
3) Adverse event rate
4) Quality of life


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 radiotherapy
A total of 70.4 GyE consisting of 16 fractions; 4.4 GyE /day for 6 or 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

16 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Pathologically diagnosed as primary bone and soft tissue sarcomas
2) Inoperative patient
(a) Diagnosed as inoperative tumor by specialized surgeons
(b) Refused by patient
3) Patient with measurable tumor
4) 16 years or older and 80 years or younger of age at registration of clinical trial
5) 0 to 2 of ECOG performance status
6) Patient without remote metastasis
7) 6 months or longer of expected survival
8) Informed consent given with document

Key exclusion criteria

1) Primary cranial tumor
2) Past history of radiotherapy for the target lesion
3) Ongoing chemotherapy or within 2 weeks after completion of the chemotherapy
4) Patient with active double cancer
5) Patient with active and intractable infection in the target lesion
6) Patient with artifacts which influence the calculation of irradiation dose
7) Other medical or psychological condition which is unsuitable for carbon-ion therapy

Target sample size

40


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 24 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

0

Results

This clinical trial was terminated for reasons of the facility.

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

Terminated

Date of protocol fixation

2016 Year 03 Month 16 Day

Date of IRB

2016 Year 03 Month 17 Day

Anticipated trial start date

2016 Year 03 Month 24 Day

Last follow-up date

2017 Year 08 Month 24 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 03 Month 22 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=R000024856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name