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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01854749
Other study ID # S1- ESCC -CJH
Secondary ID
Status Completed
Phase Phase 2
First received May 10, 2013
Last updated February 22, 2016
Start date November 2011

Study information

Verified date February 2016
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
S1 combined with cisplatin


Locations

Country Name City State
China Cancer hospital Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival from the first cycle of treatment (day one) to two month after the last cycle No
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