Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604) - Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000710

Enrollment

Registered

2007-05-08

Start date

2007-05-01

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 neoplasm

Interventions

Concurrent chemoradiotherapy with S-1 and cisplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage II or III without T4 4) Aged 20 to 70 years old 5) ECOG PS of 0 or1 6) no need for measurable lesion 7) no previous treatment of esophageal cancer 8) no previous chemotherapy or radiotherapy against any other malignancies 9) adequate water intake 10)no palsy of recurrent nerve 11) adequate organ functions 12) refused esophagectomy 13) 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) Patients requiring the administration of phenytoin or warfarin potassium 3) Pregnant or lactating women or women of childbearing potential 4) Psychosis 5) Patients requiring systemic steroids medication 6) HBs antigen positive 7) Uncontrollable diabetes millutus or requiring administration of insulin 8) Uncontrollable hypertension 9) History of myocardial infarction or unstable angina pectoris 10) Interstitial pneumonia, fibroid lung or severe emphysema 11) Active bacterial or fungous infection

Design outcomes

Primary

Measure	Time frame
Incidence of dose limiting toxicity/Complete response rate	—

Secondary

Measure	Time frame
Adverse event, Overall survival, Progression free survival	—

Countries

Japan

Contacts

Public ContactMakoto Tahara, MD, PhD

JCOG0604 Coordinating Office Outpatient division, National Cancer Center Hospital East

JCOG_sir@ml.jcog.jp04-7133-1111

Outcome results

None listed

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