JPRN-jRCTs031180207进行中（未招募）3 期
JCOG1114C: Phase III Study of High-dose Methotrexate and Whole Brain Radiotherapy With or Without Concomitant and Adjuvant Temozolomide in Patients with Primary CNS Lymphoma - PCNSL-TMZ-P3
ISHIKAWA Ryo0 个研究点目标入组 130 人开始时间: 2019年3月7日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •*First registration (after surgery)
- •(1)Histologically proven diffuse large B-cell lymphoma.
- •(2)Lymphoma originating from the central nervous system except for the spinal cord. Existence of intraocular lymphoma is eligible.
- •(3)Both solitary/multiple lesions are eligible.
- •(4)Both measurable/immeasurable lesions are eligible
- •(5)No evidence of lymphomatous meningitis confirmed by cerebrospinal fluid cytology or brain/whole spine MRI.
- •(6)No evidence of lymphomatosis cerebri.
- •(7)Postoperative date between 3 and 35 days.
- •(8)Age between 20 and 70 years at the time of study entry
- •(9)ECOG PS 0-2, or PS 3 caused by neurological deficits associated with tumors.
- •Following cases are also eligible: PS 0-2 ameliorated by administration of corticosteroids, glycerol, mannitol or corticosteroids.
- •(10)No prior treatment with chemotherapy or cranial radiotherapy as treatment for other malignancies and malignant lymphoma.
- •(11)No evidence of lymphoma outside the CNS and the eyes confirmed by CT scanning with contrast enhancement of the chest, abdomen and the pelvis.
- •(12)Adequate major organ function.
- •(13)Written informed consent.
- •*Second registration (after HD-MTX treatment)
- •(1)At least one cycle of HD-MTX treatment administered
- •(2)Between 10 and 21 days after the HD-MTX treatment.
- •(3)ECOG performance status: 0-2 or 3 due to neurological deficits.
- •(4)Brain MRI with gadolinium enhancement after HD-MTX was implemented.
- •(5)CSF cytology negative
- •(6)No evidence of lymphoma outside the CNS and the eyes
- •(7)Ocular lesions are evaluated by fundus examination under mydriasis and slit lump examination.
- •(8)No infection or appetite loss of grade 3 or higher. No evidence of pneumonitis of grade 2 or higher.
- •(9)No fever of 38C or higher suggestive of infection.
- •(10)Adequate organ function.
排除标准
- •First registration (after surgery)
- •(1)Concurrent malignancies (concurrent double cancer or metachronous cancer within 5 years) excluding basal cell carcinoma of the skin or cervical carcinoma in situ.
- •(2)Concurrent infectious diseases necessitate systemic treatment.
- •(3)HIV antibody positive.
- •(4)HBs antigen positive
- •(5)HCV antibody positive
- •(6)Patients with immune deficiency syndrome such as AIDS, X-linked agammaglobulinemia, chronic granulomatous diseases or Wiskott-Aldrich Syndrome.
- •(7)Organ transplant patients.
- •(8)Body temperature more than 38C.
- •(9)Infectious meningitis necessitating treatment.
- •(10)Pregnant or lactating patients.
- •(11)Concurrent psychiatric problems.
- •(12)Those under treatment with continual use of insulin or with the complication of uncontrolled diabetes mellitus.
- •(13)Evidence of unstable angina (onset within 3 weeks or deteriorating symptoms) or history of cardiac infarction within 6 months.
- •(14)Concurrent pulmonary fibrosis or interstitial pneumonia.
- •(15)Patients for whom both gadolinium and iodine contrast media cannot be applied because of allergy
研究者
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