Unique ID issued by UMIN | UMIN000013537 |
---|---|
Receipt number | R000015793 |
Scientific Title | A phase II clinical trial of carbon-ion radiotherapy using 2 fractions for hepatocellular carcinoma smaller than and equal to 30mm |
Date of disclosure of the study information | 2014/04/01 |
Last modified on | 2019/04/01 08:56:26 |
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
Japan |
hepatocellular carcinoma
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Malignancy
NO
To evaluate the safety and efficacy of carbon-ion radiotherapy using 2 fractions for small hepatocellular carcinoma.
Safety,Efficacy
3-year local control rate
Overall survival
Cause-specific survival
Normal tissue reaction
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Carbon-ion beam
Total dose 48.0 GyE
2 fractions
Not applicable |
Not applicable |
Male and Female
1) The patient with single liver tumor diagnosed hepatocellular carcinoma pathollogically or clinically.
2) The tumor is measurable and the maximum diameter of the tumor is smaller than and epual to 30mm.
3) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
4) The Child-Pugh score of the patient is from 5 points to 8 points.
5) Perfomance status of the patient is from 0 to 2.
6) Life expectancy of the patients is longer than one year.
7) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
1) Patient recieved any other therapies for hepatocellular carcinoma within 4 weeks from the first day of the carbon-ion radiotherapy.
2) The alimentary tract is included in and adjacent to the planning target volume.
3) Patient with ascites.
4) Patient with hepatic encephalopathy.
5) Patient with sever paraesophageal varix or portal hypertention.
6) Patient with intractable esophageal or gastric varix.
7) Patients with any other active malignancies.
8) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is planned.
35
1st name | |
Middle name | |
Last name | Yoshiyuki Shioyama |
SAGA HIMAT foundation
Ion Beam Therapy Center
415 Harakoga-machi, Tosu, Saga 841-0071 Japan
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
1st name | |
Middle name | |
Last name | Shingo Toyama |
SAGA HIMAT foundation
Ion Beam Therapy Center
415 Harakoga-machi, Tosu, Saga 841-0071 Japan
0942-81-1897
toyama-shingo@saga-himat.jp
SAGA HIMAT foundation
SAGA HIMAT foundation
Non profit foundation
Japan
NO
佐賀国際重粒子線がん治療財団 九州国際重粒子線がん治療センター(佐賀県)
2014 | Year | 04 | Month | 01 | Day |
Unpublished
No longer recruiting
2014 | Year | 03 | Month | 24 | Day |
2014 | Year | 03 | Month | 24 | Day |
2014 | Year | 04 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 27 | Day |
2019 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015793