Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.
Interventions
DRUGoxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 20 years or older * Histologically confirmed squamous cell carcinoma of esophagus * Curatively (R0) resected, lymph node positive * ECOG performance status of 0 or 1 * Restoration of oral intake \>1500 kcal/d * No prior chemotherapy except for neoadjuvant ones * No prior radiotherapy within 1 month before registration * Adequate marrow, hepatic, renal and cardiac functions * Provision of a signed written informed consent
Exclusion criteria
* Severe co-morbid illness and/or active infections * Prior treatment with oxaliplatin * Pregnant or lactating women * Active CNS metastases not controllable with radiotherapy or corticosteroids * Known history of hypersensitivity to study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | 36 months |
Countries
South Korea
Contacts
Primary Contactmi yeon kwon, RN
Outcome results
None listed