NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy
|Carcinoma, Non-Small-Cell Lung||Drug: Chemotherapy with platine Drug: Chemotherapy without Cisplatine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.|
- progression-free survival (PFS) [ Time Frame: one year ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Drug: Chemotherapy with platine
Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
Active Comparator: B
Drug: Chemotherapy without Cisplatine
Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel).
Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases.
Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV.
- Patients are most often in a good condition (performance status 0-1).
- Progression is often asymptomatic and diagnosed in the post surgical follow up.
- The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV.
- The time between the first line of treatment and the treatment of the relapse is longer.
These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet instead of the classical mono chemotherapy docetaxel or pemetrexed.
Thus, the current study has been designed to answer these questions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535275
Show 78 Study Locations
|Principal Investigator:||Denis Moro-Sibilot, Pr||University Hospital, Grenoble|