Unique ID issued by UMIN | UMIN000015550 |
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Receipt number | R000018067 |
Scientific Title | Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma |
Date of disclosure of the study information | 2014/10/28 |
Last modified on | 2016/11/02 08:43:22 |
Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma
EC-CPT-P1
Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma
EC-CPT-P1
Japan |
Esophageal Cancer
Gastroenterology | Radiology | Adult |
Malignancy
NO
To determine the recommended dose of proton beam therapy for esophageal cancer concurrently with chemotherapy of CDDP and 5-FU
Safety
Exploratory
Phase I
Proportion of dose limiting toxicity
Adverse event, Complete response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Device,equipment |
Proton beam therapy concurrently with chemotherapy
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma
2) Primary lesion are located within the thoracic esophagus
3) Clinical stage IB or II or III (non-T4)
4) Aged 20 to 75 years old
5) ECOG PS of 0 or1
6) adequate organ functions
7) no previous treatment of esophageal cancer except EMR or ESD
8) no previous chemotherapy or radiotherapy against any other malignancies
9) written informed consent
1. Active double cancer
2. Active infection
3. Body temperature is under 38 centigrade
4. Possible pregnancy
5. Severe psychological disease
6. Systemic steroid user
7. Positive HBs antigen
8. Uncontrolled diabetes
9. Uncontrolled hypertension
10. Unstable angina, cardiac infarction within 6 months before enrollment
11. Interstitial pneumonitis, pulmonary fibrosis, severe emphysema, heart failure
12. Cerebrovascular disease within 6 months before enrollment
13. History of iodine allergy
12
1st name | |
Middle name | |
Last name | Tetsuo Akimoto |
National Cancer Center Hospital East
Radation oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
takimoto@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Masakatsu Onozawa |
National Cancer Center Hospital East
Radation oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
maonozaw@east.ncc.go.jp
National Cancer Center Hospital East
National Cancer Center Hospital East
Self funding
NO
国立研究開発法人 国立がん研究センター東病院
2014 | Year | 10 | Month | 28 | Day |
Unpublished
Open public recruiting
2014 | Year | 09 | Month | 18 | Day |
2014 | Year | 10 | Month | 29 | Day |
2014 | Year | 10 | Month | 28 | Day |
2016 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018067
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