S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study

February 22, 2016 updated by: Chang Jian Hua, Fudan University
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Cancer hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Joined the study voluntarily and signed informed consent form;

  • Age 18-75

    .Presence of at least one index lesion measurable by CT scan or MRI

  • recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • PS ECOG 0-1
  • Life expectancy of more than 3 months

  • ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L

    • Cr≤1.0×UNL
    • TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL

Exclusion Criteria:

  • there is radical cure of the cancer

    • uncontrolled chronic diarrhea and esophageal obstruction
    • Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases
    • Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia
    • Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix
  • accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S1 combined with cisplatin
Drug: S1 combined with cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
from the first cycle of treatment (day one) to two month after the last cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1- ESCC -CJH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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