Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
3 other identifiers
interventional
26
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Dec 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2004
CompletedFirst Posted
Study publicly available on registry
April 8, 2004
CompletedStudy Start
First participant enrolled
December 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
September 27, 2011
CompletedJune 29, 2023
June 1, 2023
2.6 years
April 7, 2004
December 30, 2010
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
1-year Neurologic (Central Nervous System, CNS) Progression Free Rate
assessed every 3 months for 2 years
Time to Non-CNS (Systemic) Progression
assessed every 3 months for 2 years
Overall Survival Time
assessed every 3 months for 2 years
Study Arms (1)
Temozolomide and Radiation
EXPERIMENTALTemozolomide:administered orally. Radiation: whole brain radiation therapy
Interventions
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.
Standard whole brain radiation therapy 30 Gy in ten fractions.
Eligibility Criteria
You may qualify if:
- Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Bronchoalveolar carcinoma
- All variants of NSCLC
- At least 1 bidimensionally measurable brain metastasis
- Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is not acceptable
- Biopsy is not required
- Not eligible for surgical resection or radiosurgery of 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
- +15 more criteria
You may not qualify if:
- HIV positive
- AIDS-related illness
- Poor medical risks due to active nonmalignant systemic disease
- Frequent vomiting
- There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
- Pregnant or nursing
- Prior temozolomide
- Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
- Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
- Other concurrent investigational agents
- Other concurrent treatment for brain metastasis
- Other concurrent chemotherapy during study radiotherapy
- Concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- Eastern Cooperative Oncology Group (ECOG) Statistical Office
Study Officials
- STUDY CHAIR
H. I. Robins, MD, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2004
First Posted
April 8, 2004
Study Start
December 20, 2005
Primary Completion
August 1, 2008
Study Completion
February 1, 2009
Last Updated
June 29, 2023
Results First Posted
September 27, 2011
Record last verified: 2023-06