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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00154804
Other study ID # 900603
Secondary ID
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated August 22, 2007
Start date August 2001
Est. completion date April 2004

Study information

Verified date April 2004
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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


Description:

The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Pathologically proven SCC or adenocarcinoma of esophagus .

2. Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)

3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .

4. Age ? 18 ys

5. KPS ? 60%

6. 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 .

Exclusion Criteria:

1. Invasion to surrounding organ ( T4 disease ) .

2. Distant metastasis , except M1a disease .

3. Patients who refuse operation .

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel, Cisplatin,Surgery, CCRT


Locations

Country Name City State
Taiwan Department of Oncology, Nationa Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical and pathological response rates 2000~2004
Secondary Progression free survival 2000~2004
Secondary overall survival 2000~2004
Secondary Toxicity 2000~2004
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