A pilot study of low-concentration hydrogen peroxide exposure radiotherapy for low radiosensitive tumors and bulky tumors that are unresectable and ineligible for standard chemotherapy

JRCT ID: jRCTs061220053

Registered date:30/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Hematologic Malignancies
• Date of first enrollment: 30/08/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): low-concentration hydrogen peroxide exposure radiotherapy

Outcome(s)

• Primary Outcome: Local control ratio

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <=3.0 mg/dL
d. AST <=150 U/L
e. ALT <=150 U/L
f. SpO2 (room air) >=90%
9. Written informed consent

Exclude 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

Related Information

• Primary Sponsor: Tamaki Yukihisa
• Source(s) of Monetary Support: Shimane University Hospital