CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer
Phase 2
Completed
- Conditions
- Esophageal Cancer
- Interventions
- Drug: Paclitaxel, Cisplatin,Surgery, CCRT
- Registration Number
- NCT00154804
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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 .
Exclusion Criteria
- Invasion to surrounding organ ( T4 disease ) .
- Distant metastasis , except M1a disease .
- Patients who refuse operation .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Paclitaxel, Cisplatin,Surgery, CCRT -
- Primary Outcome Measures
Name Time Method Clinical and pathological response rates 2000~2004
- Secondary Outcome Measures
Name Time Method Progression free survival 2000~2004 overall survival 2000~2004 Toxicity 2000~2004
Trial Locations
- Locations (1)
Department of Oncology, Nationa Taiwan University Hospital
🇨🇳Taipei, Taiwan