NCT00535275

NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Relapses after perioperative chemotherapy and surgery

Detailed description

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2007-09-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2007-09-26
• Last updated: 2015-02-16

Locations

78 sites across 1 country: France