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Prognostic Factor Analysis in Metastatic Esophageal Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01472419
First received: November 11, 2011
Last updated: April 7, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472419

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

No publications provided

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
Study First Received: November 11, 2011
Last Updated: April 7, 2013
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013