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CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00154804
First Posted: September 12, 2005
Last Update Posted: August 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Condition Intervention Phase
Esophageal Cancer Drug: Paclitaxel, Cisplatin,Surgery, CCRT Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Clinical and pathological response rates [ Time Frame: 2000~2004 ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 2000~2004 ]
  • overall survival [ Time Frame: 2000~2004 ]
  • Toxicity [ Time Frame: 2000~2004 ]

Enrollment: 40
Study Start Date: August 2001
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: A Drug: Paclitaxel, Cisplatin,Surgery, CCRT

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154804


Locations
Taiwan
Department of Oncology, Nationa Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chih-Hung Hsu, M.D.,Ph.D. Department of Oncology, National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, M.D.,Ph.D Department of Oncology, National Taiwan University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00154804     History of Changes
Other Study ID Numbers: 900603
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: August 23, 2007
Last Verified: April 2004

Keywords provided by National Taiwan University Hospital:
Concurrent Chemoradiotherapy
Esophageal Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action