Unique ID issued by UMIN | UMIN000015306 |
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Receipt number | R000017795 |
Scientific Title | Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer |
Date of disclosure of the study information | 2014/10/01 |
Last modified on | 2019/04/05 12:44:56 |
Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Japan |
Esophageal neoplasm
Gastroenterology | Radiology |
Malignancy
NO
To estimate the maximum tolerated dose and to determine the recommended dose of intensity-modulated radiation therapy for locally advanced unresectable thoracic esophageal cancer
Safety
incidence of (1) Grade 3 or more esophagitis, (2) Grade 2 or more radiation pneumonitis, (3) Grade 2 or more conduction disorder/pericardial effusion/pericarditis/acute coronary syndrome within 90 days after intensity-modulated radiation therapy and (4) more than 60 days of treatment duration to finish a radiation therapy due to adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Chemoradiotherapy consists of 5-FU (700 mg/m2, day 1-4, day 29-32), cisplatin (70 mg/m2, day 1, 29) and intensity-modulated radiation therapy (66-72 Gy/30 fr: 66 Gy/30 fr at level 1, 69 Gy/30 fr at level 2 and 72 Gy/30 fr at level 3), followed by adittional two courses chemotherapy with 5-FU (800 mg/m2, day 1-5) plus cisplatin (80 mg/m2, day 1).
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma located in the thoracic esophagus
2) Clinical stage IIIC or IV with supraclavicular lymph node metastasis
i)Primary tumor invasion depth T4
ii)Metastatic regional lymph node(s) invasion to adjacent organ
3) No esophageal fistula
4) No aortic invasion
5) Aged 20 to 75 years old
6) ECOG Performance status 0 or 1
7) Adequate organ functions
8) Written informed consent
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) Fever over 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychosis
6) Patients requiring systemic steroids medication
7) Serum HBs antigen positive
8) Uncontrolled diabetes mellitus
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
10) Interstitial pneumonia, fibroid lung, or severe emphysema
11) With a history of cerebrovascular disorder within 6 months
12) Connective tissue disease
13) History of radiation therapy to chest
14) History of surgery for esophageal cancer
18
1st name | |
Middle name | |
Last name | Masahiro Hiraoka |
Graduate School of Medicine and Faculty of Medicine Kyoto University
Department of Radiation Oncology and Image-Applied Therapy
54, Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
075-751-3419
hiraok@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Katsuyuki Sakanaka |
Graduate School of Medicine and Faculty of Medicine Kyoto University
Department of Radiation Oncology and Image-Applied Therapy
54, Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
075-751-3762
sakanaka@kuhp.kyoto-u.ac.jp
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine and Faculty of Medicine Kyoto University
Ministry of Education, Culture, Sports, Science and Technology
NO
2014 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 24 | Day |
2014 | Year | 10 | Month | 10 | Day |
2014 | Year | 10 | Month | 10 | Day |
2018 | Year | 12 | Month | 31 | Day |
2014 | Year | 10 | Month | 01 | Day |
2019 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017795
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