Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02162537 : Therapeutic Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Brain Metastases
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Patients with histologically or cytologically proven non-epidermoid, non-small cell
lung cancer, non-EGFR (Epidermal Growth Factor Receptor)-mutated (or mutation test
impracticable).

2. Patients with brain metastasis/metastases without neurosurgical indication.

3. 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).

4. At least one lesion measurable according to the RECIST (Response Evaluation Criteria
in Solid Tumors) criteria.

5. ECOG (Eastern Cooperative Oncology Group) Performance Status 0 - 1

6. No previous chemotherapy for this cancer, apart from adjunctive chemotherapy more than
18 months ago.

7. Prior surgery is authorized in case of documented recurrence or progression.

8. Adequate biological functions (hematologic, platelets, hemoglobin, hepatic function,
alkaline phosphatases, ASAT (Aspartate transaminase) and ALAT (Alanine
Aminotransferase); creatinine clearance).

9. For women: Effective contraception for women of childbearing age during treatment and
for 6 months following treatment.

For men: They must be surgically sterile or accept the use of effective contraception
until 6 months after the treatment period.

10. Patients of more than 18 years of age.

11. Estimated survival of at least 12 weeks.

12. Consent signed by the patient

Exclusion Criteria:

1. Patients presenting with a brain lesion eligible for curative treatment
(neurosurgical).

2. Symptomatic brain metastasis/metastases in spite of symptomatic treatment.

3. Epidermoid carcinoma.

4. Con indication of Bevacizumab is furthermore

5. Patients presenting with a brain lesion eligible for curative treatment (neurosurgery
or radiosurgery).

6. Symptomatic brain metastasis/metastases in spite of symptomatic treatment.

7. Epidermoid carcinoma.

8. Cons indication of Bevacizumab

9. Inability to take the folic acid or vitamin B12 vitamin supplementation or the
dexamethasone premedication (or any equivalent corticosteroid), or any inability to
comply with the study procedures.

10. History of cancer, with the exception of cervical cancer in situ, skin cancer other
than melanoma, adequately treated low-grade prostatic cancer (Gleason score <6),
unless this cancer was diagnosed and treated more than 5 years ago without any signs
of recurrence.

11. Patients presenting with a systemic disorder which, in the investigator's opinion,
compromises their participation in the study for reasons related to treatment safety
or compliance.

12. Patients incapable of discontinuing their aspirin treatment when the dose is > 1300
mg/day or their non-steroidal anti-inflammatory treatment two days before the day, on
the day and two days the day of administration of pemetrexed (Alimta).

13. Patients presenting with a 3rd sector (pleural effusion, ascites) which is clinically
detectable and uncontrollable by simple measures of the evacuatory puncture type or
other treatment before inclusion in the study.

14. Patients presenting with neuropathy of grade > 2 according to the criteria of CTC
(Common toxicity Criteria) v3.0.

15. Patients whose foreseeable compliance or geographical distance renders monitoring
difficult.

16. Pregnant or breast-feeding women.

17. Significant weight loss (= 10%) during the 6 weeks preceding inclusion in the study.

18. Vaccination against yellow fever within 30 days preceding inclusion in the study.

19. Cons-indication to taking steroids

20. Persons deprived of their liberty as a result of a judicial or administrative decision

21. Concomitant participation in another trial
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02162537      |      Link to official Clinicaltrials.gov listing
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