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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E1F03 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo whole brain radiotherapy once daily, 5 days a week, for 2 weeks (10 fractions). Patients also receive concurrent oral temozolomide once daily on days 1-14.
Beginning 3 weeks after the completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of neurologic (Central Nervous System, CNS) progression or unacceptable toxicity.
Patients were followed every 3 months for 2 years.
ACCRUAL: A total of 26 patients were accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide and Radiation | Experimental | Temozolomide:administered orally. Radiation: whole brain radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Intracranial Response | Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR | assessed every cycle while on treatment, then every 3 months for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Neurologic (Central Nervous System, CNS) Progression Free Rate | 1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease. |
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Inclusion Criteria:
Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies:
At least 1 bidimensionally measurable brain metastasis
Systemic disease not in immediate need of chemotherapy
Age>=18 years
ECOG Performance status of 0-1
More than 12 weeks of life expectancy
Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration
Fertile patients must use effective contraception
Prior biologic therapy allowed
More than 4 weeks since prior chemotherapy
Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed
Prior surgery for brain metastasis allowed
At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for < 15% of bone marrow) and recovered
Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. I. Robins, MD, PhD | University of Wisconsin, Madison | Study Chair |
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Study Activated on 10/18/2005, accrued its first patient on 12/20/2005, terminated on 3/13/2007. Institutes include Mayo Clinic Rochester, Northwestern University, Wisconsin, University of, Stanford University, Lankenau Hospital,Toledo Community Hosp Onc Prog CCOP,Sanford Cancer Ctr-Oncology Clinic,Carle Cancer Center CCOP
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolamide and Radiation | Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolamide and Radiation | Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Patients With Intracranial Response | Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR | Eligible and treated patients | Posted | Number | participants | assessed every cycle while on treatment, then every 3 months for 2 years |
|
Assessed every cycle (cycle 1=35 days, All other cycles =28 days) while on treatment and for 30 days after the end of the treatment
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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 | Temozolamide and Radiation | Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | Eastern Cooperative Oncology Group (ECOG) Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
|
| Radiation therapy | Radiation | Standard whole brain radiation therapy 30 Gy in ten fractions. |
|
|
| assessed every 3 months for 2 years |
| Time to Non-CNS (Systemic) Progression | Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis. | assessed every 3 months for 2 years |
| Overall Survival Time | Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis. | assessed every 3 months for 2 years |
| Lack of Efficacy |
|
| other disease |
|
| Not started protocol therapy |
|
| Ineligible |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 1-year Neurologic (Central Nervous System, CNS) Progression Free Rate | 1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease. | Eligible, treated patients | Posted | Number | 95% Confidence Interval | percentage of participants | assessed every 3 months for 2 years |
|
|
|
| Secondary | Time to Non-CNS (Systemic) Progression | Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis. | Eligible and treated patients | Posted | Median | 95% Confidence Interval | months | assessed every 3 months for 2 years |
|
|
|
| Secondary | Overall Survival Time | Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis. | Eligible and treated patients | Posted | Median | 95% Confidence Interval | months | assessed every 3 months for 2 years |
|
|
|
| 10 |
| 25 |
| 21 |
| 25 |
| Thrombocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam,oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| CNS, hemorrhage | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic lower extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Radiation dermatitis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam,oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste disturbance | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT Increased | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST Increased | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |