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RATIONALE
PURPOSE
Primary Outcome Measures
Secondary Outcome Measures
Objectives
Primary
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole brain irradiation plus Temozolomide | Experimental | Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide. |
|
| Whole brain irradiation | Active Comparator | Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rates. Assessed With Cranial MRI | Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Free of Brain Metastases Progression (PFS of BM) | Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Gamboa-Vignolle, MD | Instituto Nacional de Cancerología de México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cancerología de México | México | D.F | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16134182 | Background | Jones SF, Greco FA, Gian VG, Miranda FT, Raefsky EL, Hainsworth JD, Willcutt NT, Beschorner AF, Kennerly G, Burris HA 3rd. A Phase I trial of protracted oral fixed-dose temozolomide. Cancer. 2005 Nov 1;104(9):1985-91. doi: 10.1002/cncr.21408. | |
| 12202665 | Background | Antonadou D, Paraskevaidis M, Sarris G, Coliarakis N, Economou I, Karageorgis P, Throuvalas N. Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J Clin Oncol. 2002 Sep 1;20(17):3644-50. doi: 10.1200/JCO.2002.04.140. |
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Seventy-two patients were assessed for eligibility. Twelve patients did not meet inclusion criteria. Five patients declined to participate. Fifty-five patients were enrolled.
Participants were recruited from patients from Instituto Nacional de Cancerología de México, from January 2006 to September 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Whole Brain Irradiation and Temozolomide | Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide. |
| FG001 | Whole Brain Irradiation | Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Whole Brain Irradiation and Temozolomide | Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rates. Assessed With Cranial MRI | Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants. | Data on all enrolled participants were included in an intention-to-treat analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants with OR | 90 days |
|
3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whole Brain Irradiation and Temozolomide | Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 <500 - 200 mm3. Grade 4 <200/mm3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 1 < Low limit of normal (LLN) - 800/mm3. Grade 2 <800 - 500/mm3. |
Our study had methodological limitations, such as the two temozolomide dose levels, which in future clinical trials may be adjusted to a single level.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Gamboa Vignolle/ Radiation Oncologist | Instituto Nacional de Cancerologia de Mexico | 0155556280400 | 441 | cswgamboa@yahoo.com |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Whole brain irradiation |
| Radiation |
|
|
| at 90 days |
| Overall Survival | Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up. | 1 year |
| Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment. | AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0 Grade 3 Severe AE. Grade 4 Life-threatening or disabling AE. | 4 months |
| 15629610 | Background | Verger E, Gil M, Yaya R, Vinolas N, Villa S, Pujol T, Quinto L, Graus F. Temozolomide and concomitant whole brain radiotherapy in patients with brain metastases: a phase II randomized trial. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):185-91. doi: 10.1016/j.ijrobp.2004.04.061. |
| 22257825 | Derived | Gamboa-Vignolle C, Ferrari-Carballo T, Arrieta O, Mohar A. Whole-brain irradiation with concomitant daily fixed-dose temozolomide for brain metastases treatment: a randomised phase II trial. Radiother Oncol. 2012 Feb;102(2):187-91. doi: 10.1016/j.radonc.2011.12.004. Epub 2012 Jan 16. |
| BG001 |
| Whole Brain Irradiation |
Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Whole Brain Irradiation | Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks |
|
|
|
| Secondary | Survival Free of Brain Metastases Progression (PFS of BM) | Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases. | Data on all enrolled participants were included in an intention-to-treat analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | at 90 days |
|
|
|
|
| Secondary | Overall Survival | Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up. | Data on all enrolled participants were included in an intention-to-treat analysis. | Posted | Median | 95% Confidence Interval | Months of Overall Survival | 1 year |
|
|
|
|
| Secondary | Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment. | AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0 Grade 3 Severe AE. Grade 4 Life-threatening or disabling AE. | Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity . | Posted | Number | Events | 4 months |
|
|
|
| 17 |
| 28 |
| 11 |
| 28 |
| EG001 | Whole Brain Irradiation | Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday. | 7 | 27 | 13 | 27 |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 <2000 - 1000/mm3 |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 <50,000 - 25,000/mm3. Grade 4 <25,000/mm3 |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 <1000 - 500/mm3 |
|
| Nausea-Vomiting | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 ≥6 episodes in 24 hrs; IV fluids, indicated ≥24 hrs |
|
|
| platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 1 \ |
|
| Alanine aminotransferase - Aspartate aminotransferase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Alanine aminotransferase Grade 1 > Upper limit of normal (ULN) - 2.5 x ULN Aspartate aminotransferase Grade 1 > ULN - 2.5 x ULN |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Nausea-Vomiting |
|
| Neutropenia |
|
| Platelets |
|