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

January 7, 2008
December 17, 2009
December 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01034332 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer
A Phase II Study With One-cycle Weekly TP-HDFL Followed by Twice Weekly TP-CCRT and Esophagectomy for Locally Advanced Esophageal Cancer

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
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.
Experimental: One-cycle induction chemotherapy
TP-HDFL, TP-CCRT, Esophagectomy
Intervention: Procedure: TP-HDFL,TP-CCRT, Esophagectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Taiwan
 
NCT01034332
200707051M
Yes
Chih-Hung Hsu / Department of Oncology, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Chih-Hung Hsu, M.D National Taiwan University Hospita
National Taiwan University Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP