Non-small Cell Lung Cancer Clinical Trial
Official title:
Multicentric, Randomized, Phase III Trial Comparing 2 Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Asymptomatic Brain Metastases
The patients carrying a complicated primary lung cancer brain metastases die in less than 3
months of delay disease in the absence of treatment. The median survival of these patients is
approximately six months when the treatment associated with radiotherapy chemotherapy based
on cisplatin is now the standard treatment. In most studies the patients die of their brain
disease in one case only two, so it is likely that some patients do not require brain
irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for
patients in group B (without systematic irradiation) are not to suffer the side effects of
this radiation. The risks are in the same group to see brain metastases become symptomatic.
The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear:
should all patients be irradiated systematically (since the "reference" treatment is involved
and with the aim of obtaining better control of the brain lesions and maintaining a better
neurological status) or should only the patients showing cerebral progression be irradiated
(avoidance of possibly useless brain radiotherapy and its side effects). The aim of this
study is to better determine the position of cerebral radiotherapy in this context.
Main objective:
determine whether there is a difference in terms of progression-free survival between a
therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy
cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy
cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of
cerebral progression in patients with NSCLC with asymptomatic brain metastases
This is a trial comparing two strategies with the aim to determine the best place for
cerebral radiotherapy (initially or only systematic progression).
Arm A: Initial cerebral radiotherapy and chemotherapy, standard arm Arm B: Chemotherapy and
Radiotherapy brain if clinical or radiological cerebral progression , experimental arm (The
chemotherapy treatments are standard treatments using drugs with authorization in this
indication)
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