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

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Treatments: Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01467921

2010-07-206

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

LV5FU2

Active Comparator group

Description:

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

Treatment:

Drug: oxaliplatin

FOLFOX

Experimental group

Description:

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

Treatment:

Drug: oxaliplatin