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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01467921
First received: November 6, 2011
Last updated: November 14, 2011
Last verified: November 2011

November 6, 2011
November 14, 2011
December 2010
February 2012   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01467921 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Drug: oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
  • 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
    Intervention: Drug: oxaliplatin
  • 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
    Intervention: Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
Not Provided
February 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com
Korea, Republic of
 
NCT01467921
2010-07-206
No
Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP