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Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer

RANDOMIZED STUDY OPEN PHASE 3, OF TEMOZOLOMIDE ADDED TO TOTAL RADIATION THERAPY OF THE BRAIN COMPARED WITH TOTAL RADIATION THERAPY OF THE SINGLE CEREBRUM FOR THE TREATMENT OF CEREBRAL METASTASES FROM NON-SMALL CELL LUNG CANCER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-003-04
Enrollment
5
Registered
2004-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Placebo Type of group
Subjects will be randomized to receive the corresponding placebo at a dose of 75 mg / m2 daily for 2 weeks (14 consecutive days) in conjunction with WBRT followed by an additional 7 days with placebo (21 days in total). Group name:Temozolomide Type of group
Temozolomide 150-200 mg / m2 on days 1-5 every 28 days

Sponsors

SCHERING PLOUGH RESEARCH INSTITUTE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age greater than or equal to 18 Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) At least one brain metastasis diagnosed within 30 days of randomization Brain metastases must not have been previously treated with WBRT or radiosurgery No more than 2 sites of extracranial metastases May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites Meets protocol requirements for specified laboratory values. Written informed consent and cooperation of patient Appropriate use of effective contraception if of childbearing potential. Karnofsky Performance Status KPS greater than 70 Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
Outcome name:Overall Survival Measure:Overall Survival Timepoints:all the study—

Secondary

MeasureTime frame
Outcome name:Time to radiological CNS progression Measure:Time to radiological CNS progression Timepoints:all the study—

Countries

Peru, United States

Contacts

Public ContactJorge Timoteo

SCHERING PLOUGH DEL PERU S.A.

jorge.timoteo@spcorp.com710-3653

Outcome results

None listed

Source: REPEC (via WHO ICTRP)