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Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Collaborator:
Groupe Francais De Pneumo-Cancerologie
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01631136
First received: June 26, 2012
Last updated: September 1, 2016
Last verified: September 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Advanced Non Small Cell Lung Cancer | Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Pemetrexed
U.S. FDA Resources
Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:
Primary Outcome Measures:
- Overall survival [ Time Frame: around 20 months ]
Secondary Outcome Measures:
- Disease free survival [ Time Frame: Around 5 months ]
- Control and response rate [ Time Frame: After 4 cycles ]
- 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
- treatment exposure [ Time Frame: Around 5 months ]
| Enrollment: | 932 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Continuous maintenance Therapy
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
|
Drug: Cisplatin
75 mg/m²
Drug: Pemetrexed
500 mg/m²
|
|
Experimental: Maintenance according to the response of induction
Induction chemotherapy by cisplatin + gemcitabine followed by :
|
Drug: Pemetrexed
500 mg/m²
Drug: Cisplatin
80 mg/m²
Drug: Gemcitabine
1250 mg/m²
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01631136
Show 91 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631136
Show 91 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Groupe Francais De Pneumo-Cancerologie
Investigators
| Principal Investigator: | Maurice PEROL, MD | Centre Léon Bérard - Lyon |
| Principal Investigator: | Pierre-Jean SOUQUET, MD, PhD | Centre Hospitalier Lyon Sud |
More Information
Additional Information:
| Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT01631136 History of Changes |
| Other Study ID Numbers: |
IFCT-GFPC-1101 |
| Study First Received: | June 26, 2012 |
| Last Updated: | September 1, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
|
Non Small Cell Lung Cancer IFCT Maintenance Switch |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Cisplatin Pemetrexed |
Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 22, 2017