Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05095376
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2021-10-15
Brief Title:
Testing the Addition of the Chemotherapy Drug Lomustine Gleostine to the Usual Treatment Temozolomide and Radiation Therapy for Newly Diagnosed MGMT Methylated Glioblastoma
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
A Phase III Trial of Gleostine Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma Chemotherapy drugs such as lomustine and temozolomide work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Radiation therapy uses high energy photons to kill tumor cells and shrink tumors Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma
Detailed Description:
PRIMARY OBJECTIVE
I To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy RT significantly prolongs overall survival OS versus vs standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma GBM with MGMT promoter methylation
SECONDARY OBJECTIVES
I To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy RT significantly prolongs progression-free survival PFS vs standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation
II To compare the two different chemotherapy regimens on patient-reported outcomes PROs as measured by the MD Anderson Symptom Inventory - Brain Tumor MDASI-BT in patients with newly diagnosed GBM with MGMT promoter methylation
III To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy RT is associated with inferior short-term change in patient reported outcomes PROs as measured by MDASI-BT vs standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation
IV To assess toxicity in the two different chemotherapy regimens
EXPLORATORY OBJECTIVES
I To assess the association between absolute lymphocyte counts and outcomes II To assess the association between CD4 lymphocyte counts and outcomes III To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo radiation therapy 5 days per week and receive temozolomide orally PO once daily QD for 6 weeks in the absence of disease progression or unacceptable toxicity Patients then receive temozolomide PO QD on days 1-5 Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity
ARM II Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6 Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for year 1 every 4 months for year 2 and then every 6 months thereafter
I To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy RT significantly prolongs overall survival OS versus vs standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma GBM with MGMT promoter methylation
SECONDARY OBJECTIVES
I To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy RT significantly prolongs progression-free survival PFS vs standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation
II To compare the two different chemotherapy regimens on patient-reported outcomes PROs as measured by the MD Anderson Symptom Inventory - Brain Tumor MDASI-BT in patients with newly diagnosed GBM with MGMT promoter methylation
III To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy RT is associated with inferior short-term change in patient reported outcomes PROs as measured by MDASI-BT vs standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation
IV To assess toxicity in the two different chemotherapy regimens
EXPLORATORY OBJECTIVES
I To assess the association between absolute lymphocyte counts and outcomes II To assess the association between CD4 lymphocyte counts and outcomes III To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo radiation therapy 5 days per week and receive temozolomide orally PO once daily QD for 6 weeks in the absence of disease progression or unacceptable toxicity Patients then receive temozolomide PO QD on days 1-5 Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity
ARM II Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6 Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for year 1 every 4 months for year 2 and then every 6 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180868 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180868 |
| NCI-2021-10331 | REGISTRY | None | None |
| NRG-BN011 | OTHER | None | None |
| NRG-BN011 | OTHER | None | None |