Clinical trial · Interventional
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
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
NCT01398449CI-TRIAL-00005243unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemotherapy only | Other | — | UNRESOLVED |
| Elective nodal irradiation (ENI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B
- description
- After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
- interventionNames
- Radiation: Elective nodal irradiation (ENI)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
- interventionNames
- Other: Adjuvant chemotherapy only
Primary outcomes (1)
- measure
- Overall survival
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 and ≤70 2. ECOG 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. Stage T1-2N1-3M0 based pathological diagnosis 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 normal 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.