A phase II Study of total marrow and lymphoid irradiation with intensity modulated radiotherapy using TomoTherapy

Murofushi Keiko0 个研究点目标入组 28 人开始时间: 2023年7月20日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•1. Disease status is non-remission period, or predicted poor prognosis equivalent to High / Very high on the Refined disease risk index.
•2. Aged from 16 to 59 years old.
•3. ECOG Performance status of 0 - 2.
•4. Adequate function of major organs within 28 days prior to study enrollment and met the following a)-h) criteria.
•a) Echocardiogram : Left ventricular cardiac ejection fraction of >= 50%.
•b) 12-lead electrocardiogram : No abnormal findings that require treatment.
•c) Arterial oxygen saturation >= 94% without inhaling oxygen. (Measurement by non-invasive oxygen saturation monitoring is also acceptable.)
•d) Pulmonary function test: %VC >= 70% and FEV1/FVC >= 70%.
•e) Serum total bilirubin =< 2.0 mg/dL AND AST and ALT =< 5 x upper limit of normal.
•f) Creatinine clearance >= 30 mL/min. Predicted values based on Cockcroft-Gault equation are also acceptable.
•g) No diabetes mellitus poorly controlled with insulin.
•h) No psychiatric disorders requiring treatment with a major tranquilizer.
•5. Written informed consent is obtained. If the case of a minor, the consent of a surrogate must be obtained.

•1. Patients not met the inclusion criteria.
•2. Extramedullary or extranodal disease.
•3. Synchronous or metachronous (within 5 years) malignancies.
•4. Difficulty in maintaining rest during radiation therapy.
•5. Patients who are technically difficult to irradiate with TomoTherapy (cannot fit in the treatment gantry, overweight, or difficult to calculate the dose).
•6. Pregnant or potentially pregnant patients.
•7. History of allogeneic or autologous transplantation.
•8. Patients determined to be intolerant to hematopoietic stem cell transplantation, including chemotherapy and TMLI as a conditioning regimen.
•9. Other conditions judged as inappropriate for the study by the investigator.

发起方

Murofushi Keiko