Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma
|ClinicalTrials.gov Identifier: NCT01735747|
Recruitment Status : Unknown
Verified March 2013 by Rongjie Tao, Shandong Cancer Hospital and Institute.
Recruitment status was: Active, not recruiting
First Posted : November 28, 2012
Last Update Posted : March 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Tumors||Radiation: Radiotherapy Drug: nedaplatin Drug: vincristine Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2013|
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.
- Rate of complete radiologic response (CR) [ Time Frame: 3 years ]final data collection date for primary outcome measure
- Failure-free survival [ Time Frame: 3 years ]
- Toxicity [ Time Frame: 3 years ]
- Overall response rate [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|