Treatment of brain metastases (MTSC) by Whole Brain Radiotherapy (WBRT) and temozolomide (TMZ) concomitant - TEM09

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014481-26-IT

Enrollment

120

Registered

2009-10-01

Start date

2009-09-29

Completion date

Unknown

Last updated

2014-03-17

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

Conditions

patients with brain metastases are not resectable, a departure from solid tumors such as breast, lung, melanoma

Interventions

Trade Name: TEMODAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Informed consent-written and signed; -Age &#8805; 18 years; -Consideration histological / cytological known from the primary tumor; -At least one lesion measurable by repetitive cerebral CT and / or MRI with mdc, not candidates for surgery or radiosurgery; -No-encephalic radiotherapy made previously; -Cancer-therapy earlier interrupted by at least 2 weeks or depending on the adopted scheme of chemotherapy, where q 21, q 14, or q 7, respectively performed by three, two, or 1 week. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Severe comorbidity; -Women in pregnancy or lactation; -Pz, with single metastases, candidates for surgery or SRT; -Stroke-past cerebral vascular known; -MTS-cerebral bleeding; -MTS-brain from an unknown primary tumor; -Symptomatic cerebral atrophy present before treatment; -Treatment-encephalic radiotherapy performed previously, including SRT; -Treatment-chemotherapy in progress; antiblastic with chemotherapy drugs or with a molecular target, or ormonoterapia in progress.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase II study of feasibility, efficacy and tolerance of combined treatment of TMZ and WBRT in patients with solid tumors MTSC as lung, breast, melanoma.;Secondary Objective: Secondary end points were the assessment of changes in cognitive ability after RT, and overall survival.;Primary end point(s): The primary endpoint of the study is the radiological response, assessed at 28 days after the end of concomitant radio-chemotherapy.	—

Measure

Time frame

Main Objective: Phase II study of feasibility, efficacy and tolerance of combined treatment of TMZ and WBRT in patients with solid tumors MTSC as lung, breast, melanoma.;Secondary Objective: Secondary end points were the assessment of changes in cognitive ability after RT, and overall survival.;Primary end point(s): The primary endpoint of the study is the radiological response, assessed at 28 days after the end of concomitant radio-chemotherapy.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026