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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01467921
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma	Drug: oxaliplatin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LV5FU2 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	Drug: oxaliplatin; oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
Experimental: FOLFOX 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	Drug: oxaliplatin; oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h

Outcome Measures

Primary Outcome Measures

1. disease-free survival [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01467921
• Other Study ID Numbers: 2010-07-206
• First Posted: Nov 9, 2011
• Last Update Posted: Nov 16, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Oxaliplatin

Study Results

No Results Posted as of Nov 16, 2011