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

Last updated: November 14, 2011
Sponsor: Samsung Medical Center
Overall Status: Trial Status Unknown

Phase

2

Condition

Digestive System Neoplasms

Esophageal Disorders

Carcinoma

Treatment

N/A

Clinical Study ID

NCT01467921
2010-07-206
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 68
Study Start date:
December 01, 2010
Estimated Completion Date:

Connect with a study center

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

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