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Recruitment status Terminated
Unique ID issued by UMIN UMIN000021557
Receipt No. R000024856
Official scientific title of the study 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 2017/06/05

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Basic information
Official scientific title of the study A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection
Title of the study (Brief title) 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

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
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

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
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 Dr. Yuko Nakayama
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Department of Radiotherapy
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Email nakayamy@kcch.jp

Public contact
Name of contact person Dr. Yuko Nakayama
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Department of Radiotherapy
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Homepage URL
Email nakayamy@kcch.jp

Sponsor
Institute Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
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 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

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

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 03 Month 16 Day
Anticipated trial start date
2016 Year 03 Month 24 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
2016 Year 03 Month 22 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024856


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