Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal cancer, Esophagectomy, Paclitaxel, Induction chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TP-HDFL,TP-CCRT, Esophagectomy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
National Taiwan University Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Chin-Hung Hsu, MD - 02-23123456 - chihhunghsu@ntu.edu.tw
Start Date
December 2007
Completion Date
December 2009
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page