Unique ID issued by UMIN | UMIN000021557 |
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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 |
A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection
Carbon-ion radiotherapy for inoperative bone and soft tissue sarcomas (iROCK-1503BS)
A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection
Carbon-ion radiotherapy for inoperative bone and soft tissue sarcomas (iROCK-1503BS)
Japan |
Bone and soft tissue tumor
Orthopedics | Radiology |
Malignancy
NO
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
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Local control rate at 2 years
1) Overall survival
2) Progression free survival
3) Adverse event rate
4) Quality of life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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
16 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
40
1st name | Hiroyuki |
Middle name | |
Last name | Katoh |
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Department of Carbon-ion Radiotherapy
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
hkatoh@kcch.jp
1st name | Hiroyuki |
Middle name | |
Last name | Katoh |
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Ion-beam Radiation Oncology Center
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
hkatoh@kcch.jp
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Self funding
Japan
None
None
Kanagawa Cancer Center IRB
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
clinical_trials@kcch.jp
NO
神奈川県立がんセンター(神奈川県)
2016 | Year | 03 | Month | 24 | Day |
Unpublished
0
This clinical trial was terminated for reasons of the facility.
2023 | Year | 12 | Month | 25 | Day |
Terminated
2016 | Year | 03 | Month | 16 | Day |
2016 | Year | 03 | Month | 17 | Day |
2016 | Year | 03 | Month | 24 | Day |
2017 | Year | 08 | Month | 24 | Day |
2016 | Year | 03 | Month | 22 | Day |
2023 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024856
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