Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Phase 2

• Conditions: Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
• Interventions: Drug: oxaliplatin

• Registration Number: NCT01467921
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-11
• Study First Submitted: 2011-11-06
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Submitted: 2011-11-14
• Last Update Posted: 2011-11-16
• Primary Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LV5FU2	oxaliplatin	leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2
FOLFOX	oxaliplatin	leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h

Primary Outcome Measures

Name	Time	Method
disease-free survival	36 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of