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A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer


Phase 3
N/A
70 Years
Open (Enrolling)
Both
Thoracic Esophageal Squamous Cell Carcinoma

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Trial Information

A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer


According to different location of the primary lesion,the subject can be allocated to two
sub-groups:

The patient with upper or middle thoracic esophageal cancer may be assigned to two
field(T)-total mediastinal lymphadenectomy group,which is control group in this study or
three field lymphadenectomy-Abdominal + mediastinal + cervical lymphadenectomy group,which
is study group in this study randomly.

The patient with lower thoracic esophageal cancer may be assigned to three different
groups:two field(S)-standard mediastinal lymphadenectomy group, which is control group in
this study,or two field(T)-total mediastinal lymphadenectomy,which is the first study group
in this study,or three field lymphadenectomy group which is the second study group in this
study randomly.

After the operation,the patient whose primary lesion is completely(R0) resected will be
assigned to adjuvant chemotherapy group or interview group randomly.


Inclusion Criteria:



1. Age≤70 years old;

2. Karnofsky Performance Status(KPS)≥80;

3. Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is
treated initially;

4. Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic
ultrasonography,chest and abdomen CT and neck ultrasonic.

5. The preoperative evaluation of organ function is tolerant of surgery and
chemotherapy;

6. The subject can understand and sign the informed consent form (ICF);

7. The following laboratory tests, made in 4 weeks before first medication, confirmed
that bone marrow, liver and kidney function in line with the requirements to
participate in research; Hemoglobin(HGB)≥9.0g/L; absolute neutrophils
count(ANC)≥1.5×109/L; platelet count(PLT)≥100×109/L; total
bilirubin(TBIL)≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine
aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial
thromboplastin time(APTT) is in normal range;endogenous creatinine clearance
rate(CRE)≤1.5N.

Exclusion Criteria:

1. Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal
cancer;

2. Advanced Esophageal Cancer;

3. Prior malignancy in 5 years recently;

4. History of previous chest radiotherapy;

5. History of cardio-cerebral vascular accident in 6 months lately;

6. The subject can not understand and sign the informed consent form(ICF).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

survival rate

Outcome Description:

Disease-free survival overall survival

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Peng Lin, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

651, Dongfeng Road East, Guangzhou, P. R. China

Authority:

China: Ethics Committee

Study ID:

2007044

NCT ID:

NCT01137123

Start Date:

April 2010

Completion Date:

September 2016

Related Keywords:

  • Thoracic Esophageal Squamous Cell Carcinoma
  • esophageal squamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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