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Prognostic Factor Analysis in Metastatic Esophageal Squamous Cell Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472419
First Posted: November 16, 2011
Last Update Posted: April 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
  Purpose
Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP) chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line chemotherapy. Clinicopathologic variables and treatment outcome were retrospectively collected. we analysis treatment outcome of palliative chemotherapy in metastatic esophageal squamous cell carcinoma and make prognostic scoring system. The present study represents the largest series to analyze the treatment outcome of FP/XP chemotherapy in metastatic SCC. Risk-adapted stratification of treatment for subgroup of metastatic SCC patients should be actively pursued.

Condition
Metastatic Esophageal Squamous Cell Carcinoma

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Fluoropyrimidine/Platinum-based First-line Chemotherapy in Metastatic Esophageal Squamous Cell Carcinoma: Prognostic Factor Analysis in 239 Patients

Resource links provided by NLM:


Further study details as provided by Jeeyun Lee, Samsung Medical Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 12 month ]

Enrollment: 239
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Between January 2000 to December 2010, 239 patients were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line chemotherapy.
Criteria

Inclusion Criteria:

  • recurrent, metastatic esophageal SCC
  • received either FP or XP as first-line chemotherapy.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472419


Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jeeyun Lee, M.D., Ph.D. Samsung Medical Center, Seoul, Korea
  More Information

Responsible Party: Jeeyun Lee, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01472419     History of Changes
Other Study ID Numbers: SMCESOPROGNOSIS
First Submitted: November 11, 2011
First Posted: November 16, 2011
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by Jeeyun Lee, Samsung Medical Center:
metastatic esophageal squamous cell carcinoma
Fluoropyrimidine/platinum-based first-line chemotherapy
prognosis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases