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A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Phase 2
18 Years
70 Years
Open (Enrolling)
Esophageal Squamous Cell Carcinoma

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Trial Information

A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes
removed for adequate nodal staging.

T3-4, any N, M0.


After esophagectomy, patients are firstly stratified by 2 factors: (1)number of lymph node
metastasis (<3 or >=3) and (2)tumor resection status (R1 resection or R2 resection).

Note: Pathological R0 resection status is required for this study. So here R1 and R2
resection are not actually pathological status of resection, only clinical judgement by
physician based on the chest-CT before esophagectomy.

Then patients are randomized to 2 arms:

Arm A:

Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential
chemotherapy (4 cycles).

Arm B:

Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).

Inclusion Criteria:

1. Age ≥ 18 and ≤70

2. Performance status 0-1

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

4. Registration within 8 weeks after esophagectomy

5. Histologically proven primary thoracic esophageal squamous cell carcinoma

6. R0 resection and number of lymph nodes dissected ≥15 after esophagectomy

7. Pathological stage of T3-4N0-3M0

8. Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT
scan is selective)

9. Without supraclavicular nodes and abdominal regions nodes existed after surgery

10. Without neo-adjuvant chemotherapy and radiotherapy

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

12. Platelets ≥ 100X109/L

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

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

15. Creatinine ≤ 1.5 x upper limit of normal

16. 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:

3.1 Unstable angina and/or congestive heart failure requiring hospitalization within
the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of
registration 3.4 Chronic obstructive pulmonary disease exacerbation or other
respiratory illness requiring hospitalization or precluding study therapy at the time
of registration 3.5 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

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:


Outcome Description:

To evaluate if the survival outcome of postsurgical radiation with a small target volume involved tumor bed only is not worse than a large volume (tumor bed and elective nodes) for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.

Safety Issue:


Principal Investigator

Xiao-Long Fu, M.D, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


People's Republic of China: State Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • thoracic esophageal squamous cell carcinoma
  • esophagectomy
  • radiation
  • tumor bed
  • elective nodal irradiation
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms