Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|