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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854749
• Other study ID #: S1- ESCC -CJH
• 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. 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

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

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