TerminatedPhase 3

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

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.

France95 participantsStarted 2013-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with histologically or cytologically proven non-epidermoid, non-small cell lung cancer, non-EGFR (Epidermal Growth Factor Receptor)-mutated (or mutation test impracticable).
✓. Patients with brain metastasis/metastases without neurosurgical indication.
✓. Asymptomatic patients (without treatment or with stable steroids or antiepileptic treatments for ≥ 5 days prior to obtaining the baseline MRI of the brain, and ≥ 5 days prior to first dose of study treatment (Cycle 1, Day 1).
✓. At least one lesion measurable according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
✓. ECOG (Eastern Cooperative Oncology Group) Performance Status 0 - 1
✓. No previous chemotherapy for this cancer, apart from adjunctive chemotherapy more than 18 months ago.
✓. Prior surgery is authorized in case of documented recurrence or progression.
✓. Adequate biological functions (hematologic, platelets, hemoglobin, hepatic function, alkaline phosphatases, ASAT (Aspartate transaminase) and ALAT (Alanine Aminotransferase); creatinine clearance).

Exclusion criteria

What they're measuring

To compare the progression-free survival rate in both arms

Timeframe: From date of the randomization until the date of first detection of progression, or until the date of death, assessed up to up to approximately 90 months

Trial details

NCT IDNCT02162537

SponsorCentre Hospitalier Intercommunal Creteil

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03

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