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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015306

Enrollment

Registered

2014-10-01

Start date

2014-10-10

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 (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 le

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

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 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKatsuyuki Sakanaka

Graduate School of Medicine and Faculty 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