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Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer

NCT ID: NCT01034332

Last Updated: 2009-12-18

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-12-31

Brief Summary

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We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.

Detailed Description

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We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.in order to test this hypothesis, we thus propose this phase II clinical study to verify the role of "response to one-cycle induction chemotherapy"in the prediction of pathologic complete response rate to CCRT and tje outcomes for patients with loco-regional esophageal cancer.

Conditions

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Esophageal Cancer

Keywords

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Esophageal cancer Esophagectomy Paclitaxel Induction chemotherapy

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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One-cycle induction chemotherapy

TP-HDFL, TP-CCRT, Esophagectomy

Group Type EXPERIMENTAL

TP-HDFL,TP-CCRT, Esophagectomy

Intervention Type PROCEDURE

To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT) in patients with locally advanced esophageal cancer.

Interventions

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TP-HDFL,TP-CCRT, Esophagectomy

To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT) in patients with locally advanced esophageal cancer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pathologically proven esophageal cancer
* Locally advanced diseases T3 N0-1 M0; T1-3 N1 M0; T1-3 or N0-1 M1a
* Age ≥ 18 years old
* ECOG ≤ 2
* Creatinine \< 1.5 mg/dl AST, ALT \< 2.5 x upper normal limits Bilirubin \< 2.0 mg/dl
* WBC \> 4,000/μl or ANC\>2,000/μl
* Platelet \> 100,000//μl
* Informed consent

Exclusion Criteria

* Invasion to surrounding organs (T4 disease)
* Distant mets (except M1a)
* Prior thoracic irradiation
* Presence of other squamous cell carcinoma of aerodigestive way
* Symptomatic co-morbid diseases
* Previous malignancy
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

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Chih-Hung Hsu, M.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospita

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Hung Hsu, M.D

Role: CONTACT

Phone: 886-2-23711174

Email: [email protected]

Facility Contacts

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Chin-Hung Hsu, MD

Role: primary

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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200707051M

Identifier Type: -

Identifier Source: org_study_id