Esophageal squamous cell cancer
Conditions
Interventions
Proton radiotherapy group:Proton radiotherapy
Proton plus carbon ion radiotherapy group:Proton plus carbon ion radiotherapy
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients sign the informed consent form; 2. Patients aged between 18 and 80 years old; 3. The esophageal lesion was classified as esophageal squamous cell carcinoma by cytology or histology; 4. Primary esophageal carcinoma evaluated as stage II-IV by imaging analysis (stage IV only with bilateral supraclavicular lymph node metastasis included); 5. Deemed medically inoperable or declined surgery; 6. ECOG 0-2; 7. Adequate organ function: a) Complete blood count: White blood cell count (WBC) = 3.5 × 10^9/L,absolute neutrophil count (ANC) = 1.8 x 10^9/L, platelet count = 75 x 10^9/L, hemoglobin = 10 g/dL; b)Adequate hepatic functioning: ALT and AST = 1.5 * upper limit of normal(ULN), bilirubin = 1.5 * ULN; c) Adequate renal functioning: Adult endogenous creatinine clearance rate no less than 80ml/min or serum creatinine = ULN, BUN = ULN; and urine protein < 2+, otherwise 24-hour urine will be obtained to assess 24-hour urine protein = 1g ; d) Cardiac function: no severe pulmonary hypertension, cardio-cerebral vascular disease, peripheral vascular disease, severe chronic heart disease and other complications that may affect the radiotherapy; cardiac function (NYHA classification) is grade =II; 8. The tumor location needs to meet with the requirements of radiation field layout; The patient can lie in supine or prone position for more than 30 minutes in the required positioning for treatment. After respiratory control technology is adopted,the movement amplitude induced by respiratory movement of tumor and normal tissue along the beam projection must be <= 5mm.
Exclusion criteria
Exclusion criteria: 1. Patient's disease has not been pathologically confirmed; 2. Distant metastases other than supraclavicular lymph node meatstases detected by imaging analysis; or deep ulcers (i.e. the top of the ulcer extends beyond the outer membrane of the esophagus) detected by esophagography with iodinated oil (thin barium); or severe chest and back pain before treatment presented. 3. The patient had other malignant tumors,or received radiotherapy before; 4. Have not met with the treatment requirements owing to poor hepatic,renal,hematologic function; 5. Patients fail to meet with the minimum target dose coverage and limitations of dose volume requirements, or cannot meet with the dose constraints of normal organs in the radiotherapy plan designing; 6. Patients with cardiac pacemaker or other metal prosthesis implants that may be interfered of its normal function by high-energy radiation delivery or may affect the dose distribution of the irradiated target area; 7. Drug abuse or alcohol dependence; 8. Pregnancy (via serum or urine ß- HCG test) or during lactation; 9. Patients with serious comorbidities that may affect the progression of radiotherapy, including: a) Acute infectious diseases; or acute active phase of chronic infection; b) Unstable angina pectoris, congestive heart failure, myocardial infarction requiring hospitalization in the past 6 months; c) Exacerbations of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization; d) Severely impaired immune function; e) Ataxia telangiectasia and other diseases which are excessive sensitivity to radiation; f) HIV positive, including previously taking antiretroviral treatment; Chronic hepatitis B virus replication phase; Hepatitis C active phase; Active stage of syphilis; g) Patients with HBV positive, hepatitis virus replication phase, need to receive antiviral therapy, but cannot because of concomitant diseases; h) Patients with mental illness that may affect the progression of radiotherapy; i) Other diseases that may affect carbon ion radiotherapy; 10. Patients are unable to understand the purpose of treatment or unwilling/unable to sign the informed consent form; 11. Having no civil capacity or limited civil capacity; 12. Patients who will not be benefit from carbon-ion radiotherapy by physician judgement 13. Patients was considered as inappropriate to participate in clinical research by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate;Severe esophageal toxicities related to radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate;Overall survival rate; | — |
Countries
China
Contacts
Public ContactKai-Liang Wu
Shanghai Proton and Heavy Ion Center
Outcome results
None listed