NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032180029

Registered date:22/10/2018

Dose escalation study of chemo-proton therapy for esophageal cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedEsophageal Cancer
Date of first enrollment12/02/2015
Target sample size12
Countries of recruitment
Study typeInterventional
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 OutcomeProportion of dose limiting toxicity
Secondary OutcomeAdverse event, Complete response rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1) 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 criteria1. 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

Contact

Public contact
Name Hidehiro Hojo
Address Kashiwanoha 6-5-1, Kashiwa city, Chiba Chiba Japan 277-8577
Telephone +81-4-7133-1111
E-mail 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
E-mail takimoto@east.ncc.go.jp
Affiliation National Cancer Center Hospital East