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