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

Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Randomized Phase II Study of Leucovorin, 5-fluorouracil With or Without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01467921
• Other study ID #: 2010-07-206
• Status: Recruiting
• Phase: Phase 2
• First received: November 6, 2011
• Last updated: November 14, 2011
• Start date: December 2010

Study information

• Verified date: November 2011
• Source: Samsung Medical Center
• Contact: mi yeon kwon, RN
• Phone: +82-2-3410-1248
• Email: miyeon.kwon[@]samsung.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
• Esophageal Neoplasms

Intervention

Drug:
• oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		36 months	No