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OpenTrials
Completed

NCT Number: NCT01631136

Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

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.

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Key information

Conditions

Advanced Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Abbeville - CH, Abbeville, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-squamous NSCLC histologically or cytologically confirmed
  • Stage IV with a cytologically or histologically confirmation for an unique metastasis
  • No EGFR activating mutation or indeterminate EGFR mutational status
  • At least one measurable lesion
  • Age between 18 and 70
  • PS 0 or 1

Exclusion criteria

  • squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
  • Knowledge of ALK gene rearrangement
  • Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy
  • Superior venous cave syndrome except if treated by implantation of a prosthesis
  • Previous anti-tumoral treatment
  • Concomitant radiotherapy

Treatment and study plan

Cisplatin

Drug

75 mg/m²

Pemetrexed

Drug

500 mg/m²

Gemcitabine

Drug

1250 mg/m²

Primary outcomes

  1. Overall survival

    Time frame: around 20 months

Secondary outcomes

  1. Disease free survival

    Time frame: Around 5 months

  2. Control and response rate

    Time frame: After 4 cycles

  3. Safety analysis

    Time frame: Around 5 months

    Number of patients with at least one adverse event in each arm and number of adverse events with the relationship, intensity and the cycle of appearance

  4. treatment exposure

    Time frame: Around 5 months

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • Groupe Francais De Pneumo-Cancerologie

Registry information

Official study title

Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2012
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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