Patients with non small cell lung cancer (NSCLC) have a high risk of developing brain metastasis, up to 40% as evaluated in autopsy studies. These patients are often heavily symptomatic and their life expectancy remains limited (median 5.4 months), using corticosteroids and radiotherapy or radiosurgery alone.
Conditions
Interventions
Trade Name: Temodal
Product Name: Temodal
Pharmaceutical Form: Capsule, hard
Sponsors
AESCA Pharma GesmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Prior histologic confirmation of NSCLC ·Optional: NSCLC histologic confirmation of metastasis of NSCLC ·Presence of bidimensionally measurable disease in the brain ·No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin. ·Age: > 18 years ·No evidence of progression at extracranial sites ·Karnofsky Performance status ³ 60 % ·ANC > 1.500/mm3 , platelets > 100.000/mm3, hemoglobin > 8g/dl ·Serum creatinine and bilirubine 2 weeks from initiating treatment with TMZ ·Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with TMZ ·Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception ·Written informed consent 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: ·Chemotherapy or biologic therapy within four weeks prior initiating therapy with TMZ ·Prior radiation therapy for brain < 4 weeks from initiating therapy with TMZ ·Surgery within two weeks prior to TMZ administration ·Known HIV disease ·Acute infection requiring intravenous antibiotics ·Rapid disease progression outside of brain at study entrance. ·Any reason making compliance to the protocol improbable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess safety and toxicity of concomitant chemotherapy with TMZ at low dose during the whole brain radiation and later on at the 14 days on/14days off schedule in patients with cerebral metastases. ;Secondary Objective: As additional parameters progression free survival at 6 month (PFS-6) and the duration of overall survival (OS) will be recorded and compared to patients receiving radiation therapy alone. Evaluation of Quality of Life analysis (EORTC QLQ-C 30 + Brain Cancer module) and evaluation of neurological functioning during treatment (optional) using the Mini Mental Score and the EFIT test (Edinburgh Functional Impairment Test), consisting of the nine hole peg test, the ten meter walk test, Boston Aphasia rating scale and the Williams Delayed Recall Test.;Primary end point(s): The objective of this trial is to assess safety and toxicity of concomitant chemotherapy with Temozolomide (TMZ) at low dose during the whole brain radiation and later on at the two weeks on, two weeks off schedule in patients with cerebral metastases from non small cell lung cancer (NSCLC). | — |
Countries
Austria
Outcome results
None listed