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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154804
• Other study ID #: 900603
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: August 22, 2007
• Start date: August 2001
• Est. completion date: April 2004

Study information

• Verified date: April 2004
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 .

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Paclitaxel, Cisplatin,Surgery, CCRT

Locations

Country	Name	City	State
Taiwan	Department of Oncology, Nationa Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and pathological response rates		2000~2004
Secondary	Progression free survival		2000~2004
Secondary	overall survival		2000~2004
Secondary	Toxicity		2000~2004