Skin Cancer
Conditions
Interventions
FLASH-RT group:The prescription dose reference point was at the maximum dose point of 9 MeV electron beam ( subcutaneous 2.2 cm), and the source target distance was 100 cm. The prescription dose was 2
Sponsors
Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ( 1 ) Aged 18-75 years, gender unlimited. ( 2 ) Malignant tumors confirmed by biopsy. ( 3 ) The patient 's chest, abdomen, pelvic CT and other examinations showed no distant metastasis. ( 4 ) The patient 's hematopoietic function and general condition were acceptable ( white blood cell > 2.5 * 10^9 / L, platelet > 50 * 10^9 / L, bilirubin no more than 1.5 times the upper limit of normal, liver function alanine aminotransferase, aspartate aminotransferase no more than 2.5 times the upper limit of normal, renal function creatinine no more than 1.5 times the upper limit of normal ). ( 5 ) No congestive heart failure, unstable angina pectoris or unstable arrhythmia occurred in the past 6 months. ( 6 ) The Eastern Cooperative Oncology Group ( ECOG ) score was 0-2. ( 7 ) Standard treatment is poor or ineffective. ( 8 ) Disease progression brings risks to patients. ( 9 ) Superficial skin tumors, superficial metastases ( depth <= 3.5cm ), etc. ( 10 ) Electron beam FLASH-RT is expected to bring benefits to patients. ( 11 ) Expected treatment side effects are limited and controllable. ( 12 ) Patients have a strong willingness to treat. ( 13 ) A FLASH-RT treatment team consisting of four radiation oncologist, three radiation physicists and one oncologist was established. ( 14 ) No antibiotics, hormones, immunosuppressive drugs, probiotics, etc.were used within 1 month before treatment. ( 15 ) Be able to comply with the plan during the study period. ( 16 ) Sign the informed consent.
Exclusion criteria
Exclusion criteria: ( 1 ) pregnant or lactating women. ( 2 ) Patients with a history of other malignant diseases in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. ( 3 ) For patients with uncontrolled epilepsy, central nervous system diseases or mental disorders, the clinical severity may hinder the signing of informed consent or affect the patient 's compliance with drug treatment. ( 4 ) Clinically severe ( i.e., active ) heart disease, such as symptomatic coronary heart disease, New York Heart Association ( NYHA ) class II or more severe congestive heart failure or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months. ( 5 ) known major active infection, or researchers determine the presence of major blood, kidney, metabolism, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant diseases. ( 6 ) The baseline blood routine and biochemical indexes of the subjects did not meet the following criteria : hemoglobin >= 90g / L ; absolute neutrophil count ( ANC ) >= 1.5 × 10^9 / L ; platelet >= 100 × 10^9 / L ; aLT, AST = 30 g / L. ( 7 ) Deep tumor ( depth > 3.5 cm ) ( 8 ) Allergic to any study drug ingredients. ( 9 ) Other situations that the researchers believe are not suitable for enrollment. ( 10 ) Compliance with exit criteria ( 11 ) Other treatments were used at the same time so as to affect the evaluation ; ( 12 ) The use of research drugs is inconsistent with the clinical program ; ( 13 ) Adverse events and serious adverse events occurred, it is not appropriate to continue to accept the test ; ( 14 ) Poor compliance of subjects :
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;acute radiation-related toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| tumor response; | — |
Countries
China
Contacts
Public ContactLuo Hui
Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University
Outcome results
None listed