Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2020-01-31
Target enrollment:
Participant gender:
Summary
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but
IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is
better than monotherapy in term of overall survival and progression free survival. The
current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles).
After the treatment is stopped until progression and initiation of a second line treatment.
The risk of this strategy is to be confronted to a rapid disease progression during the free
interval. Indeed, about 1/3 of the patients whose disease was controlled after the
chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous
therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of
1st line (induction chemotherapy).
There is two types of maintenance :
- continuous maintenance therapy which consists in continuing the treatment initially
associated with platinum until disease progression.
- switch maintenance which consists in introducing a new treatment after the end of
induction chemotherapy The two types are validated by several trials. The marketing
authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.
Gemcitabine has a good tolerance profile which make possible the use in a maintenance
strategy. Several trials evaluated maintenance with this product and some show benefits in
term of progression free survival.
The objective of this trial is to evaluate the switch maintenance in elderly patient with a
controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
Phase:
Phase 3
Details
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique