Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT00298415
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel + Carboplatin — DRUG
    Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
  • Monotherapy (gemcitabine or vinorelbine) — DRUG
    Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)

Study Details

The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin is feasible in elderly patients and the retrospective analysis of two studies of the comparing SWOG, one this association with that of cisplatine and vinorelbine and the other cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients and more, the absence of significant difference of survival and toxicity compared to the younger patients. The study recently published of Lilenbaum and Al shows that among patients with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous cells in a repeated way with shorter intervals without allowing the emergence of resistant clones and by allowing an increase in the intensity of amount. This mode of administration appeared at the same time effective and tolerated very well among patients of more than 70 years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70 years old to patients and more was carried out in France taking again this association carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test having included 51 patients highlighted a median of 10,42 months survival (IC 95%: 7,29-17,05)

Key Dates

Start date
Mar 31, 2006
Status verified
Oct 2013
Primary completion
Sep 30, 2010
Completion
Dec 31, 2011

Study Design

Enrollment
451 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    Chemotherapy (mono)
  • Experimental: B
    Chemotherapy (doublet)

Primary Outcome Measure

Overall survival [ Time Frame: 1-year ]

Related Studies