E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with brain metastases are not resectable, a departure from solid tumors such as breast, lung, melanoma |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Secondary end points were the assessment of changes in cognitive ability after RT, and overall survival. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Informed consent-written and signed; -Age ≥ 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
fattibilita` e tolleranza del trattamento combinato |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |