NCT01693432

Brief Summary

This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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
11 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

6.6 years

First QC Date

September 20, 2012

Last Update Submit

August 22, 2017

Conditions

Esophageal Neoplasms

Keywords

Esophageal neoplasmsDocetaxelS-1

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.

    1.5 years

Secondary Outcomes (4)

  • Progression free survival

    1.5 years

  • Overall survival

    1.5 years

  • Toxicity profiles

    1.5 years

  • Disease control rate

    1.5 years

Study Arms (1)

DS (docetaxel+S-1)

EXPERIMENTAL

Treatment will be delivered as a 3-week cycle. 1. Docetaxel 60 mg/m²IV on day 1 2. S-1 80 mg/m2/day PO on day 1-14

Drug: DS (docetaxel+S-1)

Interventions

DS (docetaxel+S-1)DRUG

Treatment will be delivered as a 3-week cycle. 1. Docetaxel 60 mg/m²IV on day 1 2. S-1 80 mg/m2/day PO on day 1-14

Also known as: Taxotere, TS-1
DS (docetaxel+S-1)

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus.
  • Unresectable locally advanced, recurrent or metastatic disease.
  • Measurable or evaluable disease by RECIST criteria 1.1.
  • Minimum age of 18 years.
  • ECOG Performance status 0-2.
  • Prior chemotherapy is not allowed.
  • More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions are outside the radiation field)
  • Adequate organ functions
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

You may not qualify if:

  • Other tumor type than squamous cell carcinoma and adenocarcinoma
  • Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without docetaxel and S-1
  • Obvious bowel obstruction unrelieved by proper management
  • Evidence of serious gastrointestinal bleeding
  • Patients with CNS metastases
  • Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
  • Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
  • Known history of cerebral or leptomeningeal metastases or neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Medical Center

Anyang, South Korea

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Docetaxeltitanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Dae Young Zang, MD, PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Young Zang, MD, PhD

CONTACT

82313803871fhdzang@hallym.or.kr

Jin Hee Jung, RN

CONTACT

82313803704jhjung23@daum.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

November 1, 2011

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

KR(1)