Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)

Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508) - Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000553

Enrollment

Registered

2006-12-21

Start date

2006-12-21

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

clinical stage I (SM1-2) esophageal cancer

Interventions

A: Combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma of the esophagus 2) All tumors are located within the thoracic esophagus 3) Depth of invasion of main tumor is evaluated as clinical SM1-2 4) Multiple intra-esophageal tumors are less or equal two lesions and all of them are M1-2 5) clinical N0/M0 6) Size of main tumor and circularity are less or equal 5cm and three fourth, respectively 7) No ulcerative lesion on tumors 8) No multiple unstained area with iodine except tumors 9) No intra-esophageal metastasis 10) No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for esophageal cancer except EMR (M1-3 tumors) 11) Aged 20 to 75 years old 12) PS of 0 or 1 13) Sufficient organ functions 14) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Iodine allergy 2) Impossible to discontinue anticoagulant or antiplatelet medications 3) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy 4) Women during pregnancy or breast-feeding 5) Psychosis 6) Systemic steroids medication 7) HBs antigen positive 8) Active bacterial or fungous infection 9) History of myocardial infarction within three months or unstable angina pectoris 10) Uncontrollable hypertension 11) Uncontrollable diabetes millutus or administration of insulin 12) Interstitial pneumonia, fibroid lung or severe emphysema

Design outcomes

Secondary

Measure	Time frame
3-year overall survival in all registered cases, progression-free survival in all registered cases, overall survival in pM1-3 and margin negative cases, overall survival in pM1-3, vascular invasion positive and margin negative cases, adverse events of EMR, adverse events of chemoradiotherapy	—

Primary

Measure	Time frame
3-year overall survival in 'pM1-3, vascular invasion positive and margin negative cases' or 'pSM1-2 and margin negative cases'	—

Countries

Japan

Contacts

Public ContactKeiko Minashi

JCOG0508 Coordinating Office Chiba Cancer Center Hospital

JCOG_sir@ml.jcog.jp043-264-5431

Outcome results

None listed

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