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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the synergy of paclitaxel and cisplatin in CCRT for esophageal squamous cell carcinoma?
How does twice weekly TP CCRT compare to standard 5-FU/cisplatin regimens in locally advanced esophageal cancer response rates?
Which biomarkers correlate with pathological complete response in NCT00154804 esophageal cancer CCRT protocol?
What are the dose-limiting toxicities of twice weekly paclitaxel/cisplatin CCRT followed by esophagectomy in phase II trials?
How do taxane-platinum combinations in neoadjuvant CCRT influence survival outcomes for T3-T4 esophageal adenocarcinoma patients?
Trial Locations
- Locations (1)
Department of Oncology, Nationa Taiwan University Hospital
🇨🇳Taipei, Taiwan
Department of Oncology, Nationa Taiwan University Hospital🇨🇳Taipei, Taiwan