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

NCT ID: NCT00154804

Last Updated: 2007-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2004-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Paclitaxel, Cisplatin,Surgery, CCRT

Intervention Type DRUG

Interventions

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Paclitaxel, Cisplatin,Surgery, CCRT

Intervention Type DRUG

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Chih-Hung Hsu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, National Taiwan University Hospital

Ann-Lii Cheng, M.D.,Ph.D

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

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Department of Oncology, Nationa Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.

Reference Type DERIVED
PMID: 26313683 (View on PubMed)

Other Identifiers

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900603

Identifier Type: -

Identifier Source: org_study_id