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

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Procedure: TP-HDFL,TP-CCRT, Esophagectomy

• Registration Number: NCT01034332
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-07
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One-cycle induction chemotherapy	TP-HDFL,TP-CCRT, Esophagectomy	TP-HDFL, TP-CCRT, Esophagectomy

Primary Outcome Measures

Name	Time	Method
To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT	2 years

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan