JRCT ID: jRCTs032180029
Registered date:22/10/2018
Dose escalation study of chemo-proton therapy for esophageal cancer
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Esophageal Cancer |
Date of first enrollment | 12/02/2015 |
Target sample size | 12 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Chemoradiation (chemotherapy 2 cycle + concurrent proton beam therapy) 5-FU: 1000mg/m2/day given on day 1 to 4, 29 to 32 CDDP: 75mg/m2 given on day 1, 29 Proton beam therapy 60 to 66CGy in 30 to 33 fractions. 1 fraction / day Additional chemotherapy (2 cycle every 28 days) 5-FU: 1000mg/m2/day given on day 1 to 4 CDDP: 75mg/m2 given on day 1 |
Outcome(s)
Primary Outcome | Proportion of dose limiting toxicity |
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Secondary Outcome | Adverse event, Complete response rate |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | 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 |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Akimoto Tetsuo |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000015550 |
Contact
Public contact | |
Name | Hidehiro Hojo |
Address | Kashiwanoha 6-5-1, Kashiwa city, Chiba Chiba Japan 277-8577 |
Telephone | +81-4-7133-1111 |
hhojo@east.ncc.go.jp | |
Affiliation | National Cancer Center Hospital East |
Scientific contact | |
Name | Tetsuo Akimoto |
Address | Kashiwanoha 6-5-1, Kashiwa city, Chiba Chiba Japan 277-8577 |
Telephone | +81-4-7133-1111 |
takimoto@east.ncc.go.jp | |
Affiliation | National Cancer Center Hospital East |