Esophageal Squamous Cell Carcinoma
Conditions
Keywords
thoracic esophageal squamous cell carcinoma, esophagectomy, radiation, tumor bed, elective nodal irradiation
Brief summary
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).
Detailed description
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. Scheme: 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).
Interventions
RADIATIONenlarge irradiation volume
In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
RADIATIONSmall volume radiation
In Arm B, postsurgical radiation target volume includes tumor bed only
DRUGcisplatin
DRUGfluorouracil
Sponsors
The First Affiliated Hospital of Soochow University
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Jiangsu Cancer Institute & Hospital
Affiliated Hospital of Jiangsu University
Zhejiang Cancer Hospital
First Affiliated Hospital of Wenzhou Medical University
Zhejiang University
The First Affiliated Hospital of Anhui Medical University
Anhui Provincial Hospital
Fujian Cancer Hospital
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
RenJi Hospital
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | — | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | — | To evaluate the incidence rate of adverse events-especially radiation-induced lung toxicity |
| Failure pattern | — | To evaluate the rationality of radiation target volumes by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences. |
Countries
China
Contacts
Primary ContactXu-Wei Cai, M.D., Ph.D.
Outcome results
None listed