Clinical trial · Interventional
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer
A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- 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)
A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| enlarge irradiation volume | Radiation | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| Small volume radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
- interventionNames
- Radiation: enlarge irradiation volume
- Drug: cisplatin
- Drug: fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy
- interventionNames
- Radiation: Small volume radiation
- Drug: cisplatin
- Drug: fluorouracil
Primary outcomes (1)
- measure
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. 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 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