Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma
Recruitment status was Active, not recruiting
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.
Central Nervous System Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Ⅱ Trial of Temozolomide Plus Concurrent Whole-Brain Radiation Followed by TNV Regimen as Adjuvant Therapy for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PCNSL)|
- Rate of complete radiologic response (CR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]final data collection date for primary outcome measure
- Failure-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Overall response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Temozolomide, Nedaplatin, Vincristine, Radiotherapy
The newly diagnosed PCNSL patients will be given concurrent temozolomide (75mg/m2, orally) daily during WBRT. Then, the TNV regimen will be given after four weeks. TNV regimen consisted of temozolomide (200mg/m2 orally, days 1-5), nedaplatin (80mg/m2 i.v., day 1), vincristine (1.4mg/m2 i.v., day 1). Each cycle was 4 weeks and a maximum of six cycles were applied.
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.
Other Names:Drug: nedaplatin
nedaplatin (80mg/m2 i.v., day 1), 28 day schedule, performed four weeks after radiotherapy.A maximum of six cycles were applied.Drug: vincristine
vincristine (1.4mg/m2 i.v., day 1)28 day schedule,performed four weeks after radiotherapy.A maximum of six cycles were applied.
Other Name: ao-xian-daDrug: Temozolomide
Temozolomide (200mg/m2 orally, days 1-5, Each cycle was 4 weeks ), performed four weeks after radiotherapy. A maximum of six cycles were applied.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735747
|Neurosurgery, Shandong Cancer Hospital and Institute|
|Jinan, Shandong, China, 250117|
|Study Director:||Yu-fang Zhu, M.D.||Shandong Cancer Hospital and Institute|
|Study Director:||Yong Wang, M.M.||Shandong Cancer Hospital and Institute|