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

Phase 2

Recruiting

• Conditions: on-Hematologic Malignancies

• Registration Number: JPRN-jRCTs061220053
• Lead Sponsor: Tamaki Yukihisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified