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
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedDecember 18, 2009
December 1, 2009
2 years
January 7, 2008
December 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
2 years
Study Arms (1)
One-cycle induction chemotherapy
EXPERIMENTALTP-HDFL, TP-CCRT, Esophagectomy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
PMID: 26313683DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chih-Hung Hsu, M.D
National Taiwan University Hospita
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 7, 2008
First Posted
December 17, 2009
Study Start
December 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 18, 2009
Record last verified: 2009-12