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

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National Taiwan University

Status and phase

Completed
Phase 2

Conditions

Esophageal Cancer

Treatments

Drug: Paclitaxel, Cisplatin,Surgery, CCRT

Study type

Interventional

Funder types

Other

Identifiers

NCT00154804
900603

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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 .

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

A
Experimental group
Treatment:
Drug: Paclitaxel, Cisplatin,Surgery, CCRT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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