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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154804
First received: September 8, 2005
Last updated: August 22, 2007
Last verified: April 2004
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00154804     History of Changes
Other Study ID Numbers: 900603
Study First Received: September 8, 2005
Last Updated: August 22, 2007
Health Authority: Taiwan: Department of Health

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
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 22, 2014