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

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ClinicalTrials.gov Identifier: NCT01034332
Recruitment Status : Unknown
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 17, 2009
Last Update Posted : December 18, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: TP-HDFL,TP-CCRT, Esophagectomy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study With One-cycle Weekly TP-HDFL Followed by Twice Weekly TP-CCRT and Esophagectomy for Locally Advanced Esophageal Cancer
Study Start Date : December 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: One-cycle induction chemotherapy
TP-HDFL, TP-CCRT, Esophagectomy
Procedure: 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.


Outcome Measures

Primary Outcome Measures :
  1. To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034332


Contacts
Contact: Chih-Hung Hsu, M.D 886-2-23711174 ext 7680 chihhunghsu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chin-Hung Hsu, MD    02-23123456 ext 7680    chihhunghsu@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chih-Hung Hsu, M.D National Taiwan University Hospita
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chih-Hung Hsu / Department of Oncology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01034332     History of Changes
Other Study ID Numbers: 200707051M
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: December 2009

Keywords provided by National Taiwan University Hospital:
Esophageal cancer
Esophagectomy
Paclitaxel
Induction chemotherapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action