Cutaneous lymphoma
Conditions
Interventions
Pilot Trial:Flash radiotherapy
Confirmatory Trial:Flash radiotherapycarcinoma and other pathological types.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, regardless of gender; 2.Patients diagnosed with skin or superficial subcutaneous tumors via histopathological or cytopathological biopsy. For recurrent or metastatic subcutaneous tumors where biopsy results are unavailable, patients may be included based on clinical diagnosis supported by multiple imaging modalities (including functional imaging) and tumor markers, provided pathological confirmation of the primary lesion or other metastatic lesions exists; 3.Tumor thickness =10 mm for skin tumors (vernier caliper measurement) or subcutaneous tumors (CT/MRI with slice thickness =15 mm for pathological lymph nodes (CT/MRI with slice thickness12 weeks post-treatment as judged by the investigator; 8. Fertile male subjects and female subjects of childbearing potential must agree to use effective contraception from informed consent signing until 6 months post-treatment. Female subjects must not breastfeed or donate eggs, and male subjects must not donate sperm during this period; 9. Subjects or their legal guardians must demonstrate understanding of the study purpose, sufficient compliance with the protocol, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of contraindications to radiotherapy, including known genetic predisposition leading to increased radiosensitivity of normal tissues or comorbid conditions causing hypersensitivity to radiotherapy; 2. Concurrent systemic therapy for tumors outside the planned treatment area; 3. Prior radiotherapy to the target tumor >=2 times, or prior stereotactic body radiotherapy (SBRT), radiosurgery, or radioactive seed implantation deemed unsuitable for additional radiotherapy by the investigator; 4. Major surgery (Grade 3 or 4 surgeries as defined by the *Clinical Application Management of Medical Technologies* enacted on May 1, 2009) within 4 weeks prior to treatment; 5. Implanted devices within the radiation field (e.g., pacemakers, defibrillators, cochlear implants, drug infusion pumps, neurostimulators, regardless of activation status) or passive implants interfering with radiotherapy; 6. Unresolved local radiation-related toxicities (CTCAE v5.0 Grade >2) from prior antitumor therapies targeting the treatment area; 7. Laboratory abnormalities: white blood cell count 180 mmHg and/or diastolic blood pressure >105 mmHg; 10. Diabetes uncontrolled post-treatment: hemoglobin A1c >9%; 11. Uncontrolled severe infectious diseases; 12. Inability to comply with the trial due to substance abuse, alcohol dependence, psychiatric/neurological disorders; 13. Active autoimmune diseases** deemed unsuitable for trial participation after medical evaluation; 14. Pregnancy or lactation; 15. Exclusion criteria: Participants who have participated in other interventional drug, biological agent or medical device clinical trials within the 30 days prior to screening; 16. Other conditions considered ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LCR;Incidence rates of Grade 3, 4, and 5 adverse events** - **Occurrence rates of Grade 3/4/5 toxicities** - **Frequency of Grade 3-5 toxic reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Usability Evaluation;Incidence rates of Grade X adverse events (AEs);AE;SAE;Deficiency vs.Defect;Laboratory examination indicators;ECOG; | — |
Countries
China
Contacts
Public ContactLiu Lie
West China Hospital of Sichuan University
Outcome results
None listed