Non-Hematologic Malignancies
Conditions
Interventions
low-concentration hydrogen peroxide exposure radiotherapy
Sponsors
Tamaki Yukihisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed as Non-Hematologic Malignancies 2. It satisfies one of the following Low radiosensitive tumors (adenocarcinoma, sarcoma, melanoma, hepatocellular carcinoma, renal cell carcinoma) Bulky tumor >= 5cm (regardless of radiosensitivity) 3. Unresectable malignant tumor 4. Ineligible for standard chemotherapy and no alternative curative treatment 5. Measurable lesions exist 6. Age 20 years or older on the date of informed consent 7. ECOG performance status (PS) of 0-3. 8. The latest laboratory test within 28 days prior to enrollment a. WBC >=2000/micro L b. Platelet >=50000 / micro L c. Total bilirubin =90% 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to hydrogen peroxide, sodium hyaluronate, Lidocaine or amide type local anesthetic 2. Uncontrollable infection 3. Disseminated intravascular coagulation 4. Unable to maintain the rest position for 20 minutes 5. Pregnant or possibly pregnant woman, or man who wants pregnancy of his partner 6. Psychological disorder difficult to participate in the study 7. Interstitial lung disease or Pulmonary fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival 2. Local Progression-Free Survival 3. Improvement ratio in symptoms 4. Evaluation of tumor progression 5. Proportion of adverse events 6. Proportion of serious adverse events | — |
Contacts
Public ContactAtsushi Ue
Shimane University Hospital
Outcome results
None listed