Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Study Overview
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Brief Summary
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Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Detailed Description
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Patient Population: Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging. R0 resection; T1-2, N+, M0. Scheme: After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (<3 or >=3). Then patients are randomized to 2 arms: Arm A: Adjuvant chemotherapy (4 cycles). Arm B: Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

Official Title
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Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Elective nodal irradiation (ENI)
* Other: Adjuvant chemotherapy only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤70 ECOG performance status 0-1 Weight is not less than 90% of it before operation Registration within 8 weeks after esophagectomy Histologically proven primary thoracic esophageal squamous cell carcinoma R0 resection and number of lymph nodes dissected ≥15 after esophagectomy Stage T1-2N1-3M0 based pathological diagnosis Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective) Without supraclavicular nodes and abdominal regions nodes existed after surgery Without neo-adjuvant chemotherapy and radiotherapy WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L Platelets ≥ 100X109/L Hemoglobin ≥ 90g/L(without blood transfusion) AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal Creatinine ≤ 1.5 x upper limit of normal Sign study-specific informed consent prior to study entry Exclusion Criteria: Multiple primary esophageal tumors 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). 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 immunosuppressive. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI) | Radiation: Elective nodal irradiation (ENI)<br> <br> |
| Active Comparator: A<br>After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only | Other: Adjuvant chemotherapy only<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0 |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control rate |  |  | 
| Safety and Tolerability (incidence rate of adverse events) | the incidence rate of adverse events, especially radiation-induced lung toxicity |  | 
| Failure pattern | To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic esophageal squamous cell carcinoma, esophagectomy, elective nodal irradiation, adjuvant chemotherapy