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Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

NCT01631136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 932

Last updated 2018-01-17

No results posted yet for this study

Summary

In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.

There is two types of maintenance strategies:

* Continuous maintenance : prolongation of the treatment initially associated with platin until progression
* Switch maintenance : introduction of a new treatment after the end of induction chemotherapy

The aim of this study is to compare two maintenance strategies

* A continuous maintenance by pemetrexed
* A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.

Conditions

  • Advanced Non Small Cell Lung Cancer

Interventions

DRUG

Cisplatin

75 mg/m²

DRUG

Pemetrexed

500 mg/m²

DRUG

Cisplatin

80 mg/m²

DRUG

Gemcitabine

1250 mg/m²

Sponsors & Collaborators

  • Groupe Francais De Pneumo-Cancerologie

    collaborator OTHER

  • Intergroupe Francophone de Cancerologie Thoracique

    lead OTHER

Principal Investigators

  • Maurice PEROL, MD · Centre Léon Bérard, Lyon

  • Pierre-Jean SOUQUET, MD, PhD · Centre Hospitalier Lyon Sud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2017-05-02
Completion
2017-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01631136 on ClinicalTrials.gov