Back to resultsS1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S1 combined with cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring ESCC
Eligibility Criteria
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
Sites / Locations
- Cancer hospital Fudan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S1 combined with cisplatin
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01854749
Brief Title
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Official Title
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
ESCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S1 combined with cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S1 combined with cisplatin
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
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