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

National Taiwan University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Procedure: TP-HDFL,TP-CCRT, Esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01034332

200707051M

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

One-cycle induction chemotherapy

Experimental group

Description:

TP-HDFL, TP-CCRT, Esophagectomy

Treatment:

Procedure: TP-HDFL,TP-CCRT, Esophagectomy