drugset / Trial / NCT02162537

Therapeutic Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Brain Metastases

NCT02162537 ↗

RandomizedParallel-groupOpen-labelOther

Summary

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

Timeline

Start
2013-12
Primary completion
2018-03
Completion
2019-01

Outcome

Outcome not reported

Stopped: “Slow inclusions due in part to a change in practices. The first chemotherapy become a standard for patients with NSCL with asymptomatic brain metastases.”

Drugs

EvaluationDrugModalityDoseRoute
Background Bevacizumab Monoclonal antibody 7.5 mg/kg —
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous