A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma

A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma - A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017668

Enrollment

Registered

2015-07-23

Start date

2017-06-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal neoplasm

Interventions

Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day 1-4, day 29-32), cisplatin (75 mg/m2, day 1, 29) and involved-field intensity-modulated radiation therapy (50.4 Gy/28 fr), followed by adittional t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma in thoracic esophagus 2)Patients refuse to receive or are unfit for a surgical resection 3) Clinical stage IB-IIIC except for cT4 (TNM 7th) 4) Aged 20 to 80 years old 5) ECOG Performance status 0 or 1 6) Adequate organ functions 7) Written informed consent

Exclusion criteria

Exclusion criteria: 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 within 1 year 8) Poorly controlled 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) History of cerebrovascular disorder within 6 months 12) Connective tissue disease 13) History of a surgical resection for esophagus

Design outcomes

Primary

Measure	Time frame
Complete response rate	—

Countries

Japan

Contacts

Public ContactKatsuyuki Sakanaka

Graduate School of Medicine, Kyoto University Department of Radiation Oncology and Image-Applied Therapy

sakanaka@kuhp.kyoto-u.ac.jp075-751-3762

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026