esophageal cancer
Conditions
Interventions
control group:In the standard irradiation dose group (50.4 Gy)
Experimental group:High dose radiotherapy group (60.0gy)
Sponsors
Wuwei Cancer Hospital of Gansu Province
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed squamous or adenocarcinoma; 2. AJCC 2017 Eighth Edition cT1-4 any N M0 (Table 5.1); 3. No distant metastasis to solid organs; 4. Never received radiation therapy for esophageal cancer; 5. No history of other malignant tumors (except for cured skin cancer and stage zero cervical cancer); 6. (1) The renal function, liver function, and bone marrow function are basically normal (serum creatinine 9.5 g/dL; (4) White blood cell count, >= 3000/ml; (5) Platelet count >= 100,000/mL). 7. Aged 18 to 80 years; 8. Good physical condition, that is, ECOG (Eastern Cooperative Oncology Group) = 6 months; 10. Before radiotherapy, the patient or his legal representative has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have esophagotracheal fistula or who are highly likely to have esophagotracheal fistula as judged by physicians: 2. Lose more than 20% of body weight within six months; 3. Pregnancy (confirmed by serum or urine ß-HCG test) or during lactation; 4. Drug or alcohol dependence; 5. AIDS patients; 6. With uncontrolled systemic, pulmonary or cardiac disease; 7. With serious comorbidities that prevent the trial protocol from proceeding smoothly, including uncontrolled comorbidities (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), addiction and/or mental illness; 8. Implantation of a pacemaker or other metal prosthesis is sufficient to affect the conduct of radiation therapy; 9. Patients with poor adherence, including those who may not be able to complete the treatment plan or receive the prescribed follow-up and testing check; 10. Had other malignant tumors (except non-malignant melanoma skin cancer or non-invasive cervical cancer); 11. Receive systemic immunotherapy or corticosteroid therapy at the same time; 12. Serum creatinine clearance rate < 30ml/min; 13. Contraindications to radiotherapy; 14. Participated in clinical trials of other drugs within 30 days before enrolling in this trial; 15. No capacity for civil conduct or limited capacity for civil conduct; 16. Any medical history, according to the investigator's judgment, may interfere with the test results or increase the risk to the patient; 17. Any condition that the physician considers inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tumor control rate;Objective tumor response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;Progression free survival ;overall survival; | — |
Countries
China
Contacts
Public ContactZhang Yanshan
Wuwei Cancer Hospital of Gansu Province
Outcome results
None listed