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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT20160706028815N3 | Registry Identifier | Iranian Registry of Clinical Trials |
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This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
This study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure. The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study. The primary endpoints of study are overall survival and progression free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-cycle arm | Experimental | After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). |
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| 6-cycle arm | Active Comparator | After completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time interval between the diagnosis and death. | up to 1 year from start of treatment |
| Progression-free survival | The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms | up to 1 year from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia | blood hemoglobin lower than 10 grams per deciliter | monthly, up to 12 months during treatment |
| Neutropenia | Blood almost mature neutrophils count lower than 1500/mm3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyed Alireza Javadinia, M.D. | Contact | 00989155728157 | Javadiniaa941@mums.ac.ir | |
| Mohammadreza Saghafi, M.D. | Contact | 00989127898938 | SaghafiMR951@mums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Mahdi Silanian Toosi, M.D. | Mashhad University of Medical Sciences | Study Director |
| Kazem Anvari, M.D. | Mashhad University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation ward of Emam Reza Hospital | Recruiting | Mashhad | Razavi Khorasan Province | 9137913316 | Iran |
It is not yet known if there will be a plan to make this available.
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
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| monthly, up to 12 months during treatment |
| Presence of alopecia | A condition in which hair is lost | monthly, up to 12 months during treatment |
| Presence of nausea | An unpleasant sense of unease, discomfort, and revulsion towards food | monthly, up to 12 months during treatment |
| Presence of vomiting | Eject matter from the stomach through the mouth. | monthly, up to 12 months during treatment |
| Omid Hospital | Recruiting | Mashhad | Razavi Khorasan Province | 917661377 | Iran |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |