A phase I/II clinical trial of carbon-ion therapy for patients with clinical stage I squamous cell carcinoma of the thoracic esophagus

A phase I/II clinical trial of carbon-ion therapy for patients with clinical stage I squamous cell carcinoma of the thoracic esophagus - A phase I/II clinical trial of carbon-ion radiotherapy for stage I esophageal squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013552

Enrollment

Registered

2014-03-31

Start date

2008-04-01

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 cancer

Interventions

Carbon-ion radiotherapy: in 12 fractions over 3 weeks. The total radiation dose is escalated from the initial dose of 43.2 GyE.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven squamous cell carcinoma of the thoracic esophagus 2.Clinical stage I (T1bN0M0) according to the Japanese classification of esophageal cancer (10th edition) 3.Measurable lesion 4.Age of 80 years or younger 5.Performance status between 0 and 2 6.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Ttumor size more than 8 cm 2.Intramural metastasis 3.Prior treatments for the esophageal lesion 4.Previous radiotherapy in the treatment area 5.Other active cancer 6.Active infection 7.Serious medical or psychological problems

Design outcomes

Primary

Measure	Time frame
Acute adverse events Response rate	—

Secondary

Measure	Time frame
Local control rate Survival rate Late adverse events	—

Countries

Japan

Contacts

Public ContactShigeo Yasuda

National Institutes for Quantum and Radiological Science and Technology QST Hospital

yasudash@qst.go.jp043-206-3306

Outcome results

None listed

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