Esophageal carcinoma
Conditions
Interventions
Radiotherapy group:Adjuvant radiotherapy was performed after medical adjuvant therapy
Control group:Close clinical follow-up after receiving medical adjuvant therapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18-80 years old 2. The ECOG PS score is 0 or 1 3. Thoracic esophageal squamous cell carcinoma 4. Radical surgery after neoadjuvant therapy 5. Edge excision State 6. Full organ and bone marrow function 7. No evidence of disease recurrence and metastasis 8. Expected survival =12 weeks 9) Subjects shall undergo all baseline laboratory assessments as required and results shall be available within 2 weeks prior to enrollment. Laboratory screening values must meet the following criteria (using CTCA version 5.0) : a. White blood cell count =2000/µL b. Neutrophil count =1500/µL c. Platelet count =100×103/µL d. Hemoglobin =9.0 g/dL e. Creatinine: Serum creatinine =1.5× upper limit of normal (ULN) or creatinine clearance > 50mL/ min (according to the Cockcroft-Gault formula) f. Female creatinine clearance =[140- age (years)]× body weight (kg)×0.85×72× blood creatinine (mg/dL) g. Male creatinine clearance =[140- age (years)]× body weight (kg)×1.00×72× blood creatinine (mg/dL) h. Aspartate aminotransferase (AST)=3 x ULN i. Alanine aminotransferase (ALT)=3 x ULN j. Total bilirubin =1.5×ULN 10) Randomization must be completed within 4 weeks of completion of surgical treatment
Exclusion criteria
Exclusion criteria: 1) Esophageal cancer disease itself should be excluded a. Cervical esophageal cancer or esophageal cancer involving the neck (the upper pole of the incisor is more than 20cm away) b. Adenocarcinoma or other pathological type c. Received preoperative radiotherapy, hyperthermia, etc 2) Past medical history and complicated diseases a. Prior history of other malignancies, unless complete remission has been achieved at least 5 years prior to study entry, and no additional treatment is required or expected to be required during the study period (exceptions include, but are not limited to, carcinoma in situ/atypical hyperplasia of the lung, or non-melanoma skin cancer; Carcinoma in situ of the bladder or colon; Cervical carcinoma in situ; Carcinoma in situ) b. Subjects with a known or suspected active autoimmune disease are allowed to be enrolled with type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers c. Patients requiring systemic treatment with corticosteroids (> 10mg daily prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to adjuvant therapy; In the absence of active autoimmune disease, inhaled or topical steroids and adrenal substitute steroids at an equivalent dose of > 10mg per day of prednisone are permitted d. Those who have symptoms or are likely to cause drug-related pulmonary toxicity or treatment-related interstitial lung disease e. All toxic side effects (except nephropathy, neuropathy, hearing loss, hair loss, and fatigue) attributable to prior antitumor therapy (preoperative induction therapy) must be restored to baseline or grade 1 before adjuvant therapy (CTCAE version 5.0); Subjects with toxicity that is attributable to prior anti-cancer therapy, is not expected to be alleviated, and leads to lasting sequelae (e.g., peripheral neuropathy following treatment with platinum/purple) are admitted to the study; Peripheral neuropathy must be remitted to Grade 2 (CTCAE version 5.0) f. Any serious or uncontrolled medical illness or active infection that, in the investigator's judgment, may increase study participation, the risks associated with adjuvant radiotherapy, or may impair the subject's ability to receive treatment under the trial protocol g. A person is known to have tested positive for HIV or to have acquired immunodeficiency syndrome (AIDS) (Note: HIV testing must be performed at a research center mandated by local regulations) 3) Other exclusion criteria (a) Prisoners or persons held in involuntary confinement b) Persons detained against their will for the treatment of mental or physical diseases (e.g., class A, class B infectious diseases)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local-regional recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease-free survival;Disease-free survival at 1, 3, and 5 years;Overall survival at 1, 3, and 5 years; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed