Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 89
Summary
- Conditions
- Chemotherapeutic Agent Toxicity
- Cognitive/Functional Effects
- Lymphoma
- Neurotoxicity
- Radiation Toxicity
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OBJECTIVES: Primary To determine median progression-free survival (PFS) in both arms on an intent-to-treat basis. Secondary To determine overall survival (OS) defined as the interval from randomization to death due to any cause. To determine treatment-related neurotoxicity rates and disease-related ...
OBJECTIVES: Primary To determine median progression-free survival (PFS) in both arms on an intent-to-treat basis. Secondary To determine overall survival (OS) defined as the interval from randomization to death due to any cause. To determine treatment-related neurotoxicity rates and disease-related cognitive deterioration in each arm, through the following methods: prospective formal neuropsychological evaluation, utilizing competing-risk methodology to account for death as a competing risk to neurotoxicity or cognitive deterioration from relapsed tumor burden/salvage treatment and incidence of clinically defined neurotoxicity as per investigator's assessment. To determine if there exists differences between the two treatment arms in terms of health-related quality-of-life and symptoms over time. To determine response (partial response (PR) and complete response (CR)) rate after methotrexate-based chemotherapy and after consolidation whole-brain radiotherapy (WBRT). To determine chemotherapy-related toxicity, measured by Common Toxicity Criteria for Adverse Effects (CTCAE), v.4.0. OUTLINE: This is a multicenter study. Patients are stratified according to Memorial Sloan-Kettering Cancer Center recursive-partitioning analysis (RPA) classification for primary central nervous system lymphoma on age and Karnofsky performance status (KPS) (Class 1: age ? 50 years vs Class 2: age > 50 years and KPS ? 70% vs Class 3: age > 50 years and KPS < 70%). Patients are randomized to 1 of 2 treatment arms.
Tracking Information
- NCT #
- NCT01399372
- Collaborators
- National Cancer Institute (NCI)
- NRG Oncology
- Investigators
- Principal Investigator: Antonio Omuro, MD Yale University
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