NCT01854749

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

4.1 years

First QC Date

May 10, 2013

Last Update Submit

February 22, 2016

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

ESCC

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (1)

S1 combined with cisplatin

EXPERIMENTAL
Drug: S1 combined with cisplatin

Interventions

S1 combined with cisplatinDRUG
S1 combined with cisplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of medical oncology

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 16, 2013

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

CN(1)