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Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502

Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502 - Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000551
Enrollment
114
Registered
2006-12-20
Start date
2006-12-01
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 Carcinoma

Interventions

A:Esophagectomy with D2 (or more) lymph node desection B:Chemoradiation 5FU 700mg/m2/day civ Day1-4, 29-32 CDDP 70mg/m2/day div Day1, 29 radiation 60Gy/30fr/6w

Sponsors

Japan Clinical Oncology Group(JCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Histologically proven esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, besaloid carcinoma) (2)all lesions are localized in thoracic esophagus. (3)The depth of main lesion is endoscopically diagnosed submucosa. (4)No lymphnode metastasis and no distant metastasis. (5)No prior chemotherapy and/or radiotherapy. Only curative endoscopic mucosal resection is allowed. (6)ages 20 years-75years (7)PS(ECOG) 0-1 (8)Normal organic function. (9)oral or written informed consent obtained before randomization

Exclusion criteria

Exclusion criteria: (1)synchronous or metachronous (within 5 years) malignancy (2)Pregnant or lactating (3)psychiatric medication (3)Systemic administration of steroids (4)HBsAg positive (5)Use of insulin injection therapy or uncontrolled diabetes mellitus (6)History of acute myocardial infarction (within 3 months) or unstable angina (7)Severe complecations (COPD, pulmonary fibrillation, heart failure etc.) (8)active bacterial infection

Design outcomes

Primary

MeasureTime frame
Overall Survival

Secondary

MeasureTime frame
Complete Response Rate, Adverse Events

Countries

Japan

Contacts

Public ContactKen Kato

JCOG0502 Coordinating Office Gastrointestinal Oncology, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed

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