Status:
COMPLETED
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
Lead Sponsor:
Huashan Hospital
Conditions:
High-grade Gliomas
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive Cancer Network (NCCN) ...
Eligibility Criteria
Inclusion
- Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)
- All patients should complete radiation therapy for primary gliomas.
- MRI showed unequivocal evidence of tumor recurrence or progression.
- The time to be enrolled should be more than 90 days after the radiation therapy.
- Written informed consent
- Eastern Cooperative Oncology Group(ECOG) score: 0-2
- The patients with recurrent gliomas were treated without dose-dense TMZ therapy before enrollment.
- Surgical interventions for recurrent gliomas are permitted and patients with no residual tumor are permitted
Exclusion
- Abnormal function of liver or renal (value more than 1.5 fold normal upper limit)
- Blood routing: Hb \< 90g/L, absolute neutrophil count≤1.5\*10\^9/L, platelet \< 100\*10\^9/L
- Pregnant or lactating women
- Allergic to administered drugs
- Radiation therapy in the previous 90 days before enrollment
- The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
- Acute infection in need of antibiotics intravenously
- Participation in other clinical trials in the 90 days before enrollment
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT02263105
Start Date
October 1 2014
End Date
June 1 2018
Last Update
July 17 2018
Active Locations (1)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040