All malignant tumors, some borderline tumors and benign tumors with indications for radiation therapy.
Conditions
Interventions
Treatment group:Radiotherapy is performed using the proton therapy system
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 to 80 years (inclusive), regardless of gender; (2) Patients with treatment-na?ve/recurrent or locally advanced tumors proven diagnosed by histopathology/cytopathology in head and neck, chest, abdomen, spine, or pelvis (if histopathology/cytopathology test of recurrent lesions is impossible, patients with clinical diagnosis of recurrent tumors by radiography including functional imaging, tumor markers, may also be included); (3) Patients with a life expectancy estimation (LEE) of = 6 months, as determined by the investigator; (4) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; (5) Without the assistance of growth factors, no blood or blood product transfusion within 14 days prior to testing, and an absolute neutrophil count (ANC) > 1.5 x 10^9/L, hemoglobin (Hb)= 9 g/dL, and platelet count > 75 x 10^9/L; (6) Renal function estimated to meet creatinine clearance (CrCl) = 50 mL/min (calculated according to the Cockcroft-Gault formula) or serum creatinine = upper limit of normal (ULN) × 1.5; (7) Prothrombin time (PT) or activated partial thromboplastin time (aPTT) = ULN × 1.5 and international normalized ratio (INR) = 1.5; (8) Hepatic function meet: a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = ULN × 2.5 in patients without liver metastases while ALT and AST = ULN × 5 in patients with liver metastases; b. Total bilirubin (TBiL) = ULN x 1.5 (for patients with known Gilbert's syndrome and serum bilirubin levels = ULN x 3 may be enrolled); (9) Subjects can tolerate proton radiation therapy assesed by physician in terms of performance status and organ function; (10) Women of reproductive age with a negative blood pregnancy test result within 7 days prior to the initial treatment. Male patients and female patients of reproductive age must be using adequate contraception measures from the signing of the informed consent form (ICF) until 12 weeks after the end of treatment; (11) Female patients must refrain from egg cell donation and breastfeeding from the signing of the ICF until 12 weeks after the end of treatment; male patients must refrain from sperm donation throughout this period; (12) Subjects or their guardians are able to understand the purpose of the trial, demonstrate adequate compliance with the protocol, and capable of giving signed ICF.
Exclusion criteria
Exclusion criteria: (1) Patients with contraindications to radiotherapy; (2) Having a pacemaker or other metal prosthesis implanted within the scope of proton therapy; (3) For the same tumor target lesion, having received two or more conventional radiotherapy treatments, or having undergone radiosurgery, or radioactive particles intertissue implantation; (4) Interventional tumor treatment has been performed on the same lesion within 6 months prior to treatment; (5) Having received or planned to receive cytotoxic drug therapy or immunotherapy within 28 days prior to treatment to 12 weeks after the end of treatment; (6) Having received antitumor therapy previously but not recovered from the toxic responses (has not recovered to = grade 2 of toxic responses, according to NCI-CTCAE V5.0, except for alopecia) (7) Prior to treatment, having received autologous stem cell transplantation within 3 months, or allogeneic stem cell transplantation within 6 months; (8) Patients having active bleeding; (9) Presence of uncontrolled systemic infections or infections requiring intravenous antibiotic therapy; (10) Patients with hypertension whose post-treatment systolic blood pressure > 180 mmHg and/or diastolic blood pressure >105 mmHg; (11) Post-treatment HbA1c >9% in patients with diabetes mellitus; (12) Having undergone major surgery within 28 days prior to treatment (for the definition of major surgery, refer to the level 3 and level 4 operations specified in the "Management Regulations for Clinical Application of Medical Technology" effective on May 1, 2009); (13) Presence of human immunodeficiency virus (HIV) infection (positive antibody test), or hepatitis C virus (HCV) infection (positive antibody test and HCV-RNA positive), hepatitis B virus (HBV) infection [HBsAg (+) and HBV-DNA = 10,000 copies/mL (2000 IU/mL)]; (14) Any of the following cardiac impairments at the time of enrollment: a. New York Heart Association (NYHA) Functional Classification cardiac disease of class III to IV; b. Angina pectoris, congestive heart failure or myocardial infarction within 6 months prior to treatment; c. Prolonged QTc interval (>470 msec in male; >480 ms in female) d. Second-degree AV block type II and third-degree AV block or PR interval >250 ms, etc; e. Factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, sudden unexplained death of a first-degree relative aged< 40 years; 6) Left ventricular ejection fraction (LVEF) <50%; (15) Comorbid psychiatric disorders and drug abuse or alcohol dependence; (16) Having participated in clinical trials of other interventional drugs, biologics or devices within 30 days prior to enrollment; (17) No capacity or limited capacity for performing civil juristic acts; (18) Non-compliance with the trial plan in terms of the organ at risk (OAR) dose constraints; (19) Having had another malignancy (Exceptions include lung carcinoma in situ, non melanoma skin cancers (NMSC), or non-invasive cervical cancer) within 5 years prior to enrollment; (20) Other conditions that, in the judgment of the investigator, are not eligible for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Control Probability, TCP; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Duration of Response, DOR;Progression-free Survival, PFS;Overall Survival, OS; | — |
Countries
P.R. China
Contacts
Public ContactJiayi Chen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed