Metastatic Esophageal Squamous Cell CarcinomaNCT01472419
Prognostic Factor Analysis in Metastatic Esophageal Squamous Cell Carcinoma
An observational study of Metastatic Esophageal Squamous Cell Carcinoma, run by Samsung Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Esophageal Squamous Cell Carcinoma
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- recurrent, metastatic esophageal SCC
- received either FP or XP as first-line chemotherapy.
Who cannot join
None listed.
About this study
Official title: Fluoropyrimidine/Platinum-based First-line Chemotherapy in Metastatic Esophageal Squamous Cell Carcinoma: Prognostic Factor Analysis in 239 Patients
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.
- Keywords
- metastatic esophageal squamous cell carcinoma, Fluoropyrimidine/platinum-based first-line chemotherapy, prognosis
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, M.D., Ph.D., Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472419
- Sponsor's protocol ID
- SMCESOPROGNOSIS
- Status last verified
- Apr 2013
- First submitted
- 11 Nov 2011
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoropyrimidine/Platinum-based First-line Chemotherapy in Metastatic Esophageal Squamous Cell Carcinoma: Prognostic Factor Analysis in 239 Patients
- ClinicalTrials.gov ID
- NCT01472419
- Acronym / sponsor ID
- SMCESOPROGNOSIS
- Keywords
- metastatic esophageal squamous cell carcinoma, Fluoropyrimidine/platinum-based first-line chemotherapy, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- recurrent, metastatic esophageal SCC
- received either FP or XP as first-line chemotherapy.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeeyun Lee, M.D., Ph.D. principal investigator
Samsung Medical Center, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Esophageal Squamous Cell Carcinoma, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.