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IRCT20150929024266N5 IRCT 2020-11-30 Tehran University of Medical Sciences Role of initiating treatment with temozolomide in Glioblastoma Comparing the effect of neoadjuvant temozolomide before chemoradiotherapy with chemoradiotherapy followed by adjuvant temozolomide on progression free survival in patients with Glioblastoma 2020-10-06 anticipated 134 Complete https://irct.ir/trial/52119 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomized into two groups by table of random numbers. 3 Glioblastoma. Intervention 1: Neoadjuvant temozolomide 3 cycles 200 mg/m2 days 1-5 in a 28 days schedule, followed by chemoradiotherapy , 60 Gy radiotherapy single phase is administered in 2 Gy fractions over 6 weeks (GTV=post-op MRI axial T1 +contrast tumor bed ,CTV=GTV+2cm smart margin), concomitantly with daily doses of temozolomide 75 mg/m2 and then 3 cycles of temozolomide dosage 200 mg/m2 days 1-5 in a 28 days schedule. If clinical symptoms and signs of progression is noted radiotherapy is initiated immediately. Intervention 2: Control group: Chemoradiotherapy, 60 Gy radiotherapy single phase is administered in 2 Gy fractions over 6 weeks (GTV=post-op MRI axial T1 +contrast and tumor bed, CTV=GTV+2cm smart margin), concomitantly with daily doses of temozolomide 75 mg/m2 6 followed by 6 cycles of temozolomide dosage 200 mg/m2 days 1-5 in a 28 days schedule. Yes - There is a plan to make this available What will be shared: The study protocol (complete), Informed consent (only the blank template), Clinical study report (as the published article) When: 6 month after the end of the study To whom: Only to academic individuals. Conditions: The written request is mandatory by email emphasizing the mentioning of study conductors in case of using data Where to obtain: By contacting this email address: rezaght@gmail.com How to obtain: The study conductors will evaluate each request due to applicants' CV and scientific portfolio. The requests will be responded by 1 month after receiving an email. Comments:
public Reza Ghalehtaki
Imam Khomeini Hospital Complex, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1461833359 +98 21 6119 2585 rghalehtaki@tums.ac.ir Tehran University of Medical Sciences scientific Reza Ghalehtaki
Imam Khomeini Hospital Complex, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1461833359 +98 21 6119 2585 rghalehtaki@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Histologically proven glioblastoma grade IV: GBM Age 18 - 80 years old Performance status WHO 0-2 Men and women of child bearing potential must be using adequate contraception Normal organ function, except if abnormal due to tumor involvement Patient 18 years 80 years Both Prior chemotherapy or radiotherapy for malignant glioma Any other active malignancies within the last 5 years, except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ Pregnancy or breast feeding Any condition (medical, social, psychological) which would prevent adequate information and follow up Platelet count (TPK) <100 x 10^9/L Hemoglobin (Hb) < 90 g/L Neutrophils: < 1.5 x 10^3/mm3 or LPK < 3.0 x 10^9/L Serum creatinine and bilirubin > 1.5 times the upper limit of normal (ULN) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) >3 x ULN C71 Malignant neoplasm of brain Treatment - Other Treatment - Other Neoadjuvant temozolomide 3 cycles 200 mg/m2 days 1-5 in a 28 days schedule, followed by chemoradiotherapy , 60 Gy radiotherapy single phase is administered in 2 Gy fractions over 6 weeks (GTV=post-op MRI axial T1 +contrast tumor bed ,CTV=GTV+2cm smart margin), concomitantly with daily doses of temozolomide 75 mg/m2 and then 3 cycles of temozolomide dosage 200 mg/m2 days 1-5 in a 28 days schedule. If clinical symptoms and signs of progression is noted radiotherapy is initiated immediately. Control group: Chemoradiotherapy, 60 Gy radiotherapy single phase is administered in 2 Gy fractions over 6 weeks (GTV=post-op MRI axial T1 +contrast and tumor bed, CTV=GTV+2cm smart margin), concomitantly with daily doses of temozolomide 75 mg/m2 6 followed by 6 cycles of temozolomide dosage 200 mg/m2 days 1-5 in a 28 days schedule. Progression free survival. Timepoint: first MRI done 2-8 weeks after treatment and then within every 2-4 months interval for 3 years, every 3-6months after that, if any clinical symptoms presents follow out would take place in shorter intervals. Method of measurement: MRI Imaging changes. Cognitive changes. Timepoint: Before initiating treatment and then after completion of each therapeutic modality, 3 times for the control group and 4 times for the intervention group. Method of measurement: MMS (Mini-Mental State) examination test. Hematologic complications. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Lab tests CBC. Overall survival (OS). Timepoint: The date of the start of treatment until the time that patients are still alive. Method of measurement: time monthly. Renal complications. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Lab tests BUN, Cr. Hepatic complications. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Lab tests AST, ALT, ALKP. Neurologic defects. Timepoint: Weekly during radiotherapy and before initiation each cycle of chemotherapy. Method of measurement: Weekly history taking presence or absence of seizure, headache, FND(focal neurological defect), dexamethasone usage. Deputy of Research, Tehran University of Medical Sciences Approved 2020-10-06 Ethics committee of Tehran University of Tehran Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex, Cancer institute Tehran Tehran Iran (Islamic Republic of)