Phase III Study of High-dose Methotrexate and Whole Brain Radiotherapy With or Without Concomitant and Adjuvant Temozolomide in Patients with Primary CNS Lymphoma (JCOG1114C, PCNSL-TMZ-P3)
- Conditions
- newly-diagnosed primary Central Nervous System (CNS) lymphoma
- Registration Number
- JPRN-UMIN000008535
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 130
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method