oral squamous cell carcinoma
Conditions
Interventions
Experimental group:Carbon ion radiation therapy
Sponsors
Gansu Wuwei Tumor Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 14 to 80 years; 2. Indications: tongue cancer, gingival cancer, buccal mucosa cancer, floor of mouth cancer, and tumors occurring in the posterior triangle of the molar teeth, including patients who cannot or refuse surgery, residual tumors after surgery, and patients who need adjuvant radiotherapy after surgery; 3. Histopathologically confirmed squamous cell carcinoma; 4. No prior treatment within 4 weeks prior to this radiotherapy: no interventional, photodynamic, or other tumor ablation therapy; surgical wound fully healed; 5. Acceptable MRI and enhanced CT scans, with no metal artifacts within the CTV; 6. No history of other malignant tumors (excluding cured skin cancer and stage 0 cervical cancer); 7. Liver, kidney, and bone marrow function essentially normal (ALT and AST 9 g/dL; white blood cell count =3.0×10^9/L; platelet count =100×10^9/L;) 8. Good physical condition, i.e., ECOG 0-2; no severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, etc., which may interfere with radiotherapy, cardiac function grade 1 (based on the New York Heart Association (NYHA) classification of cardiac function; 9. Expected survival period (after treatment) =6 months; 10. Before radiation therapy, the patient or their legal representative has signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Oral tumors not confirmed by pathology; 2. Patients who cannot lie still for 30 minutes; 3. Secondary treatment of recurrent tumors; 4. Distant metastasis has occurred; 5. Have received conventional photon/proton/carbon ion radiation therapy; 6. Have received radioactive particle implantation at the treatment site, and implants with metal prostheses may affect the dose of particle radiation therapy; 7. With claustrophobia, with pacemaker or metal prosthesis implant and unable to receive MRI examination; 8. Pacemakers or other metal implants that may be subject to high-energy radiation interference with normal function or that may affect the dose of the radiation target; 9. The dose limit of the organ at risk cannot reach the preset safe dose limit; 10. Pregnancy (confirmed by serum or urine ß-HCG test) or lactation; 11. A weight loss of more than 20% within six months; 12. Persons with AIDS, including those who have received antiretroviral treatment; Active stage of syphilis; 13. Accompanied by serious comorbiditions that prevent the successful implementation of the trial protocol, including uncontrolled systemic or co-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), drug or alcohol abuse, dependence, addiction and/or mental illness; 14. Patients with poor adherence, including those who may not be able to complete the treatment plan or receive prescribed follow-up visits and examinations; 15. Have had other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 16. There are contraindications to radiotherapy; 17. Participated in other drug clinical trials within 30 days prior to enrollment in this trial; 18. Having no capacity for civil conduct or limited capacity for civil conduct; 19. Any medical history that, in the investigator's judgment, may interfere with test results or increase patient risk; 20. Any condition in which the physician considers that participation in the trial is not appropriate, the physician determines that the patient will not benefit from carbon ion radiotherapy, or that there are other medical conditions or other factors that may affect carbon ion therapy. Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;acute and chronic toxic reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;objective remission rate; | — |
Countries
China
Contacts
Public ContactLi Xiaojun
Gansu Wuwei Tumor Hospital
Outcome results
None listed