Back to resultsCCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Paclitaxel, Cisplatin,Surgery, CCRT
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Concurrent Chemoradiotherapy, Esophageal Cancer
Eligibility Criteria
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 .
Sites / Locations
- Department of Oncology, Nationa Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Clinical and pathological response rates
Secondary Outcome Measures
Progression free survival
overall survival
Toxicity
Full Information
NCT ID
NCT00154804
First Posted
September 8, 2005
Last Updated
August 22, 2007
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00154804
Brief Title
CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer
Official Title
A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Concurrent Chemoradiotherapy, Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Cisplatin,Surgery, CCRT
Primary Outcome Measure Information:
Title
Clinical and pathological response rates
Time Frame
2000~2004
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
2000~2004
Title
overall survival
Time Frame
2000~2004
Title
Toxicity
Time Frame
2000~2004
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Hung Hsu, M.D.,Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D.,Ph.D
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, Nationa Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26313683
Citation
Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
Results Reference
derived
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CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer
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