A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III squamous cell carcinoma of the thoracic esophagus

A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III squamous cell carcinoma of the thoracic esophagus - A phase I/II clinical trial of preoperative carbon-ion radiotherapy and concurrent chemotherapy for stage II or III esophageal squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013852

Enrollment

Registered

2014-04-30

Start date

2012-09-01

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

1.Preoperative carbon-ion radiotherapy and concurrent chemotherapy. Carbon-ion radiotherapy is administered in 8 fractiss over 2 weeks. Chemothrapy consists of Cisplatin 70 mg/m2/day on days 1 and 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven squamous cell carcinoma of the thoracic esophagus 2.Clinical stage II or III (sxcluding T4) according to the Japanese classification of esophageal cancer (10th edition) 3.Measurable lesion 4.Age between 20 and 75years old 5.Performance status between 0 and 2 6.Curatively resectable 7.No previous treatments for the esophageal lesion 8.Adequate organ (bone marrow, liver, kidney and so on) functions 9.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Past hisotry of radiotherapy in the treatment area 2.Other active cancer 3.Active interstitial pneumonia 4.Active infection in the treatment area 5.HBs-Ag positive, HCV-Ab positive, HIV-Ab positive, HTKLV-1-Ab positive

Design outcomes

Primary

Measure	Time frame
Acute adverse events Response rate	—

Secondary

Measure	Time frame
Late adverse events Postoperative complications Survival rate	—

Countries

Japan

Contacts

Public ContactHitoshi Ishikawa

National Institute for Quantum and Radiological Science and Technology QST Hospital

ishikawa.hitoshi@qst.go.jp043-206-3306

Outcome results

None listed

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