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A Phase II Study With One-cycle Weekly TP-HDFL Followed by Twice Weekly TP-CCRT and Esophagectomy for Locally Advanced Esophageal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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.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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Chih-Hung Hsu, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospita

Authority:

Taiwan: Department of Health

Study ID:

200707051M

NCT ID:

NCT01034332

Start Date:

December 2007

Completion Date:

December 2009

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Esophagectomy
  • Paclitaxel
  • Induction chemotherapy
  • Esophageal Diseases
  • Esophageal Neoplasms

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