Unique ID issued by UMIN | UMIN000030762 |
---|---|
Receipt number | R000035115 |
Scientific Title | A Phase II Clinical Trial of Carbon-ion Radiotherapy for Locally Advanced Pancreatic Cancer |
Date of disclosure of the study information | 2018/01/12 |
Last modified on | 2023/12/27 11:27:40 |
A Phase II Clinical Trial of Carbon-ion Radiotherapy for Locally Advanced Pancreatic Cancer
Carbon-ion radiotherapy for pancreatic cancer (iROCK-1702PA)
A Phase II Clinical Trial of Carbon-ion Radiotherapy for Locally Advanced Pancreatic Cancer
Carbon-ion radiotherapy for pancreatic cancer (iROCK-1702PA)
Japan |
Locally Advanced Pancreatic Cancer
Radiology |
Malignancy
NO
To evaluate the efficacy and safety of carbon-ion radiotherapy for the patients with locally advanced pancreatic cancer in Kanagawa Cancer Center
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Proportion of patients who developed grade 2 or severe adverse events in the upper gastrointestinal tract within a year after irradiation (3 years of observation period)
1) Overall survival
2) Local control survival
3) Progression free survival
4) Adverse event rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
NO
No need to know
1
Treatment
Device,equipment |
Carbon-ion Radiotherapy;
4.6Gy(RBE) per day, A total of 55.2Gy(RBE) / 12 Fr
Chemotherapy;
Three consecutive administration of Gemcitabine (1000mg/m2) once a week and no administration in the fourth week
20 | years-old | <= |
Not applicable |
Male and Female
1) Patient who is diagnosed as invasive pancreatic ductal adenocarcinoma by cytological* or histopathological biopsy, OR, those who clinically diagnosed as primary malignant tumor in the pancreas, except for lymphoma
* Eligible for class IV or V
2) Patient who shows no distant metastasis by imaging studies (N0-1M0)
3) Patient who fulfills either following conditions;
- Locally advanced pancreatic cancer with non-curative resection
- Locally advanced pancreatic cancer with curative resection, but inoperative case due to complications
- Patients with locally advanced pancreatic cancer who deny the resection
4) 20 years old or more at trial registration
5) 0 to 2 of Performance Status (ECOG)
6) Patient who fulfills all the following conditions if he/she undergoes concomitant chemotherapy
All the laboratory data are measured within 7 days before trial registration.
(a) White blood cells >= 3500 /mm3
(b) Hemoglobin >= 9.0 g/dl
(c) Platelet >= 100000 /mm3
(d) Albumin >= 3.0 g/dl
(e) Total bilirubin
Patient with the history of drainage procedure: =< 2 mg/dl
Patient without the history of drainage procedure: =< 3 mg/dl
(f) GOT(AST)
Patient with the history of drainage procedure: =< 100 IU
Patient without the history of drainage procedure: =< 150 IU
(g) Serum creatinine =< 1.2 mg/dl
*These conditions are NOT required for Patient without concomitant chemotherapy.
7) Patient who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B)
8) Written consent obtained for the participation in this study
1) Patient with direct invasion in the gastrointestinal tract which fulfills either following conditions;
(a) Endoscopic findings of obvious invasion in stomach and duodenum
(b) Imaging findings, including those by computed tomography, of invasion inside the gastrointestinal tract
2) Obvious peritoneal dissemination, except for small amount of ascites or negative cytology of ascites
3) Gastric or duodenal ulcer, except for ulcer scar
4) Metallic stent for occlusive jaundice
5) Open injury or active and intractable infection in the target lesion
6) Severe complications such as severe cerebrovascular disease, intractable diabetes, severe cardiovascular disease, angina, myocardial infarction within 3 months from the onset, severe liver dysfunction, severe psychiatric disease if concomitant radiochemotherapy is selected, Severe complication which influences irradiation of carbon-ion beam such as psychiatric disease if carbon-ion radiotherapy alone is selected
7) Active and untreated double cancer, except for intraepithelial carcinoma, intramucinous carcinoma or malignancy controlled for a long-term
8) Medically or psychologically unsuitable conditions
77
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, JAPAN
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, JAPAN
045-520-2222
hkatoh@kcch.jp
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Self funding
Japan
N/A
N/A
Kanagawa Cancer Center IRB
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
clinical_trials@kcch.jp
NO
地方独立行政法人神奈川県立病院機構 神奈川県立がんセンター
2018 | Year | 01 | Month | 12 | Day |
Unpublished
30
This study confirmed safety and efficacy comparable to those reported from prior facilities.
2023 | Year | 12 | Month | 27 | Day |
Completed
2017 | Year | 11 | Month | 27 | Day |
2017 | Year | 12 | Month | 28 | Day |
2017 | Year | 12 | Month | 28 | Day |
2025 | Year | 03 | Month | 31 | Day |
2025 | Year | 03 | Month | 31 | Day |
2025 | Year | 03 | Month | 31 | Day |
2026 | Year | 03 | Month | 31 | Day |
2018 | Year | 01 | Month | 11 | Day |
2023 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035115
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