NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

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.

Status Terminated

Clinical Trial Summary

Relapses after perioperative chemotherapy and surgery

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

• NCT number: NCT00535275
• Study type: Interventional
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Status: Terminated
• Phase: Phase 3
• Start date: September 2007
• Completion date: November 2014