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A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery Versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Squamous Cell Esophageal Carcinoma

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Trial Information

A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery Versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma


Inclusion Criteria:



1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or
III, which is potentially resectable.

2. Patients must not have received any prior anticancer therapy.

3. More than 6 months of expected survival.

4. Age ranges from 18 to 70 years.

5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets
≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.

6. Karnofsky performance status more than 90.

7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.

2. Patients with concomitant hemorrhagic disease.

3. Pregnant or breast feeding.

4. Inability to use gastric conduit after esophagectomy because of a prior surgery.

5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.

6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the
cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Survival rate

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Jian Hua Fu, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

2007048

NCT ID:

NCT01216527

Start Date:

June 2007

Completion Date:

August 2014

Related Keywords:

  • Squamous Cell Esophageal Carcinoma
  • Stage IIB or III squamous cell esophageal carcinoma.
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

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