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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01034332
First received: January 7, 2008
Last updated: December 17, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Esophageal Cancer
 Procedure: TP-HDFL,TP-CCRT, Esophagectomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034332

Contacts
Contact: Chih-Hung Hsu, M.D 886-2-23711174 ext 7680 chihhunghsu@ntu.edu.tw
Contact: Chih-Hung Hsu, M.D 886-2-23711174 ext 7573 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

No publications provided

Responsible Party: Chih-Hung Hsu / Department of Oncology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01034332     History of Changes
Other Study ID Numbers: 200707051M
Study First Received: January 7, 2008
Last Updated: December 17, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013