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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
632
Abbeville - CH
Abbeville, France
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Amiens - CHU
Amiens, France
Clinique de l'Europe
Amiens, France
Annecy - CH
Annecy, France
Auxerre - CH
Auxerre, France
Overall survival
Time frame: Up to 15 months
Feasibility of treatment (number of cycles of maintenance)
Number of cycles of maintenance (median)
Time frame: 84 days on average
Progression free survival
Time frame: up to 7 months
response and stabilisation duration
Time frame: up to 7 months
Number of patient with at least one adverse event
Time frame: up to 7 months
Treatment duration
Time frame: Up to 7 months
2nd line response rate
Time frame: Up to 4 months
Number of adverse events
Time frame: Up to 7 months
2nd line overall survival
Time frame: Up to 7 months
2nd line progression free survival
Time frame: Up to 4 months
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CH de la Côte Basque
Bayonne, France
CHU Besancon - Pneumologie
Besançon, France
Blois - CH
Blois, France
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, France
...and 68 more locations