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

A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154804

Enrollment

Registered

2005-09-12

Start date

2001-08-31

Completion date

2004-04-30

Last updated

2007-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Concurrent Chemoradiotherapy, Esophageal Cancer

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.

Interventions

DRUGPaclitaxel, Cisplatin,Surgery, CCRT

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame
Clinical and pathological response rates	2000~2004

Secondary

Measure	Time frame
Progression free survival	2000~2004
overall survival	2000~2004
Toxicity	2000~2004

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026