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Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer

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

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Trial Information

Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer

Esophageal lymph node drainage area is rich, according to different sites, easy to
metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how
reasonable design the clinical target volume of lymph node drainage area has always been
controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the
easier involved lymph node area according to different sites, in order to contrast
advantages and disadvantages of the two kind of target area design,so the study was

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80

2. ECOG performance status 0-2

3. Weight is not less than 90% of it before treatment

4. Histologically proven primary thoracic esophageal squamous cell carcinoma previously
untreated stage I-III

5. Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT
scan is selective)

6. WBC ≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L

7. Platelets ≥ 100X109/L

8. Hemoglobin ≥ 90g/L(without blood transfusion)

9. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of

10. Creatinine ≤ 1.5 x upper limit of normal

11. Sign study-specific informed consent prior to study entry -

Exclusion Criteria:

1. Multiple primary esophageal tumors

2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity,
or cervix are all permissible).

3. Severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 3 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of

- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition;
note, however, that HIV testing is not required for entry into this protocol.
The need to exclude patients with AIDS from this protocol is necessary because
the treatments involved in this protocol may be significantly immunosuppressive.

4. Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception.

5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local control rate/ Inside irrational field recurrence rate

Outcome Description:

Evaluation after treatment 3 months and two years in the tumor local control and key observation radiation fields inside and outside the tumor recurrence and lymph node metastatic rate. To guide the rational clinical target volume of lymph node of esophageal cancer underwnet concurrent chemoradiotherapy and to Prolong the survival time, improve the quality of life of the patients.

Outcome Time Frame:

2 year

Safety Issue:


Principal Investigator


Investigator Role:

Study Chair

Investigator Affiliation:

The Second People's Hospital of Sichuan


China: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

September 2015

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • Esophageal squamous cell carcinoma
  • Concurrent chemoradiotherapy
  • Clinical target volume
  • Safety
  • Prognosis
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms