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Status unknownNCT01034332Updated Dec 18, 2009

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

A Phase 2 interventional study of TP-HDFL,TP-CCRT, Esophagectomy in Esophageal Cancer, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-18.

Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
58
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal cancer
  • Esophagectomy
  • Paclitaxel
  • Induction chemotherapy
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In context

Esophageal Neoplasms

1,592 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's planned enrollment of 58 is close to the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 570 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    One-cycle induction chemotherapy

    TP-HDFL, TP-CCRT, Esophagectomy

    Procedure: TP-HDFL,TP-CCRT, Esophagectomy

Interventions

  • ProcedureTP-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.

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What researchers measure

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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26313683 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01034332
Lead sponsor
National Taiwan University Hospital
First posted
Dec 17, 2009
Start date
Dec 2007
Primary completion
Dec 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Dec 18, 2009

Study contacts

Chih-Hung Hsu, M.D
Contact
chihhunghsu@ntu.edu.tw
886-2-23711174 ext. 7680
Chih-Hung Hsu, M.D
principal investigator · National Taiwan University Hospita

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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