NCT00154804

Brief Summary

CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

August 23, 2007

Status Verified

April 1, 2004

First QC Date

September 8, 2005

Last Update Submit

August 22, 2007

Conditions

Esophageal Cancer

Keywords

Concurrent ChemoradiotherapyEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical and pathological response rates

    2000~2004

Secondary Outcomes (3)

  • Progression free survival

    2000~2004

  • overall survival

    2000~2004

  • Toxicity

    2000~2004

Study Arms (1)

A

EXPERIMENTAL
Drug: Paclitaxel, Cisplatin,Surgery, CCRT

Interventions

Paclitaxel, Cisplatin,Surgery, CCRTDRUG
A

Eligibility Criteria

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

You may qualify if:

  • Pathologically proven SCC or adenocarcinoma of esophagus .
  • Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
  • M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
  • Age ≧ 18 ys
  • KPS ≧ 60%
  • Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl .

You may not qualify if:

  • Invasion to surrounding organ ( T4 disease ) .
  • Distant metastasis , except M1a disease .
  • Patients who refuse operation .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Nationa Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.

    PMID: 26313683DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

PaclitaxelCisplatinSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Chih-Hung Hsu, M.D.,Ph.D.

    Department of Oncology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Ann-Lii Cheng, M.D.,Ph.D

    Department of Oncology, National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2001

Study Completion

April 1, 2004

Last Updated

August 23, 2007

Record last verified: 2004-04

Locations

TW(1)