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Also known as Chemo-Radiotherapy with concurrent temozolomide.
Chemo-Radiotherapy with concurrent temozolomide · 1 trial · 1 indication
Time between randomization and death due to any cause. Patients without an event will be censored the last time they were known to be alive.
| Arm | Type | Description |
|---|---|---|
| Standard Arm: TMZ with concurrent RT (combined modality arm) | ACTIVE_COMPARATOR | Patients will receive a total of 21 days of Temozolomide (TMZ), with 15 days of TMZ administered daily with concurrent RT (40 Gy in 15 fractions). TMZ will be delivered at a dose of 75 mg/m2, given daily (Monday through Friday) with RT for 15 days, at least one hour before each session of RT (or per institutional site practice). After a 4-week break, patients will receive adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. If tolerated, additional cycles of TMZ may be administered at the treating investigator's discretion, according to institutional site practice. |
| Temozolomide monotherapy | EXPERIMENTAL | Patients will receive Temozolomide (TMZ) at a dose of 75 mg/m2 daily for 21 consecutive days. This will be followed 4 weeks later by adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion according to institutional site practice. |
| Name | Type | Description |
|---|---|---|
| Temozolomide monotherapy | OTHER | Temozolomide (TMZ) daily for 21 days, followed by up to 6 cycles of adjuvant TMZ, as tolerated. If tolerated, additional cycles of adjuvant TMZ may be administered. |
| Chemo-Radiotherapy with concurrent temozolomide. | COMBINATION_PRODUCT | Chemo-radiotherapy consisting of 40 Gy administered in 15 fractions on weekdays (Monday - Friday) concurrently with TMZ 75 mg/m2 daily for 21 days. This will be followed by up to 6 cycles of adjuvant TMZ (150-200 mg/m2 once daily on days 1-5 of a 28 day cycle), as tolerated. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion. |
Inclusion Criteria: 1. Newly-diagnosed, histologically proven, intracranial glioblastoma with maximal safe resection. Biopsy alone is expected if resection is not possible. MGMT promoter methylation status must be tested and the results positive (defined as all non-negative MGMT status, including i...
Chemo-Radiotherapy with concurrent temozolomide is used for the treatment of Glioblastoma Multiforme (GBM), a type of brain cancer. It is being studied in elderly and frail patients with GBM, specifically in a Phase 2 clinical trial. The treatment combines radiation therapy with the chemotherapy drug temozolomide, which is given concurrently.
Chemo-Radiotherapy with concurrent temozolomide is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ALBT. Avalon GloboCare is conducting clinical research to evaluate this treatment approach for patients with Glioblastoma Multiforme.
Chemo-Radiotherapy with concurrent temozolomide is currently in Phase 2 clinical development. It is an investigational treatment and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to further assess its safety and efficacy in patients with Glioblastoma Multiforme.
Chemo-Radiotherapy with concurrent temozolomide is being evaluated in a Phase 2 clinical trial with the identifier NCT04765514. The trial, titled 'Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients', is recruiting 107 participants in Canada. It is an active, randomized, active-controlled study that requires patients to be at least 65 years old.
Yes, Chemo-Radiotherapy with concurrent temozolomide is also known as Chemo-Radiotherapy with concurrent temozolomide. The drug is referred to by this name in clinical trial documentation and medical literature. It is an investigational combination therapy being studied for the treatment of Glioblastoma Multiforme.
Chemo-Radiotherapy with concurrent temozolomide combines radiation therapy with the chemotherapy drug temozolomide. Temozolomide is a small molecule that works by damaging the DNA of cancer cells, leading to their death. When given concurrently with radiation, it may enhance the effectiveness of the treatment for Glioblastoma Multiforme.