Central Nervous System Tumors
Conditions
Keywords
Lymphoma
Brief summary
In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin, vincristine (TNV) as the replacement of high-dose methotrexate to combine with concurrent chemoradiotherapy. Our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.
Detailed description
The best reported outcomes of PCNSL treatment are high-dose methotrexate-based chemotherapy combined with whole-brain radiation therapy (WBRT). Despite aggressive therapy, however, nearly 50% of patients will relapse within 24 months of diagnosis. Furthermore, the application of high-dose methotrexate-based regimen is complex, needing be hydrated, alkalified and detoxified, and treatment-related toxicity mortality is severe\[3,4\]. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 PCNSL patients with temozolomide concurrent chemoradiotherapy at the outset and then adjuvant chemotherapy for 6 cycles with temozolomide, nedaplatin, vincristine, as part of front-line therapy. Our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.
Interventions
RADIATIONRadiotherapy
WBRT was given five times a week at 2 gray (Gy)/d until the whole brain radiotherapy dose reached 40 gray. The patients were given concurrent temozolomide (75mg/m2, orally) daily during radiotherapy until the end of radiotherapy.
DRUGnedaplatin
nedaplatin (80mg/m2 i.v., day 1), 28 day schedule, performed four weeks after radiotherapy.A maximum of six cycles were applied.
DRUGvincristine
vincristine (1.4mg/m2 i.v., day 1)28 day schedule,performed four weeks after radiotherapy.A maximum of six cycles were applied.
DRUGTemozolomide
Temozolomide (200mg/m2 orally, days 1-5, Each cycle was 4 weeks ), performed four weeks after radiotherapy. A maximum of six cycles were applied.
Sponsors
National Natural Science Foundation of China
Rongjie Tao
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed primary CNS lymphoma. * Newly diagnosed. * ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1. * Relevant hospital examination including laboratory examination and physical examination (Chest X-ray, electrocardiogram, abdomen B ultrasonography, magnetic resonance imaging (MRI) of head and neck) must to be done, in order to exclude other system fatal diseases. * Must have adequate organ function as defined by the protocol: Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl. * Age \>/= 18 and \</= 75 years * Signed written informed consent prior to study entry.
Exclusion criteria
* Patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation. * Serious uncontrolled concurrent illness. * Previous brain radiotherapy, systemic chemotherapy. * Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol. * Any evidence of prior exposure to Hepatitis B virus. * Unable to comprehend the study requirements or who are not likely to comply with the study parameters. * Pregnant (confirmed by serum or urine β-HCG) or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete radiologic response (CR) | 3 years | final data collection date for primary outcome measure |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 3 years |
| Overall response rate | 3 years |
| Failure-free survival | 3 years |
Countries
China
Outcome results
None listed