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

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)

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40 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Paclitaxel, Cisplatin,Surgery, CCRT