Lung Cancer Clinical Trial
Official title:
A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease
management. Neurosurgery is not indicated in the majority of cases because of presence of
several lesions in the brain, failure of primary tumor control or presence of extra-cerebral
metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of
these patients in this situation is based on supportive care and whole-brain radiotherapy.
The place of chemotherapy for patients with good performance status was discussed for a long
time and it is now admitted. However, the place of new drugs such as pemetrexed, which is
currently used as a second line treatment for NSCLC, needs to be further studied. It is
known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar
effectiveness when compared to other drugs associations commonly used in this indication. In
addition, Cisplatin with Pemetrexed probably present a better safety profile.
The present study is based upon the hypothesis stipulating that the association
cisplatin-pemetrexed will be at least as efficient as the others association currently used
for treatment of NSCLC and will present a better safety profile. The primary objective of
this study is overall response rate on brain metastasis according to RECIST criteria.
Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus
pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.
The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II
study with the possibility of stopping the study early because of lack of efficacy.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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