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A phase III randomized comparison of surgery alone vs. surgery followed by adjuvant chemotherapy for patients with curatively resected esophageal cancer

A phase III, multi-center, randomized comparison of surgery alone vs. surgery followed by adjuvant chemotherapy with capecitabine and cisplatin for patients with curatively resected esophageal cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0003636
Enrollment
338
Registered
2019-03-18
Start date
2005-03-30
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The patients with pathologic T2-3 or N1 esophageal squamous cell carcinoma will be enrolled by informed consent, after 3-8weeks since curative resection of esophageal cancer. After stratified r
s opinion. For both groups, regular follow-up by chest-CT will be performed every 6months until 5 years since treatment.

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients must have histologically or cytologically documented esophageal cancer (squamous cell carcinoma) including esoophgeal squamous cell cancer of the esophagogastric junction 2) Patients who underwent curative surgical resection for esophageal ca (postop. 3-8 wks) 3) T 2-3 or N1 4) Age: 18-70 5) ECOG performance status: 0-2 6) No previous history of chemotherapy or radiation therapy 7) Adequate bone marrow, liver, kidney function 8) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Cervical esophageal cancer 2) Subject who received neoadjuvant chemotherapy, biologic therapy or radiation therapy 3) Evidence of brain metastasis 4) Concurrent serious medical or major psychiatric illness 5) Active or uncontrolled infection 6) Pregnant or lactating woman 7) Gastroesophageal junction involvement of stomach cancer 8) Synchronous or metachronous double primary cancer 9) History of other malignancy

Design outcomes

Primary

MeasureTime frame
disease free survival

Secondary

MeasureTime frame
overall survival;pattern of failure;toxicity profile;predictive markers

Countries

Korea, Republic of

Contacts

Public ContactGenehee Lee

Samsung Medical Center

genehee.lee@samsung.com+82-2-3410-1062

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 27, 2026