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A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer


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.


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 .

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical and pathological response rates

Outcome Time Frame:

2000~2004

Principal Investigator

Chih-Hung Hsu, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

900603

NCT ID:

NCT00154804

Start Date:

August 2001

Completion Date:

April 2004

Related Keywords:

  • Esophageal Cancer
  • Concurrent Chemoradiotherapy
  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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