Skip to main content
OpenTrials
Completed

NCT Number: NCT00154804

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

CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Nationa Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Paclitaxel, Cisplatin,Surgery, CCRT

Drug

Primary outcomes

  1. Clinical and pathological response rates

    Time frame: 2000~2004

Secondary outcomes

  1. Progression free survival

    Time frame: 2000~2004

  2. overall survival

    Time frame: 2000~2004

  3. Toxicity

    Time frame: 2000~2004

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2004
First posted
Sep 12, 2005
Registry last updated
Aug 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.