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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01472419
Other study ID # SMCESOPROGNOSIS
Secondary ID
Status Completed
Phase N/A
First received November 11, 2011
Last updated April 7, 2013
Start date March 2012
Est. completion date March 2013

Study information

Verified date April 2013
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 239
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- recurrent, metastatic esophageal SCC

- received either FP or XP as first-line chemotherapy.

Exclusion Criteria:

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival 12 month Yes
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