TAilored Post-Surgical Therapy in Early Stage NSCLC

NCT ID: NCT00775385

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Standard chemotherapy

Group Type ACTIVE_COMPARATOR

Standard Chemotherapy

Intervention Type DRUG

Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles

B

Customized treatment

Group Type EXPERIMENTAL

Customized Treatment

Intervention Type DRUG

Mutated EGFR : Erlotinib 150mg/day (1 year)

Wild-type EGFR or "undetermined" depends on ERCC1 status :

* ERCC1 high : no treatment
* ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Chemotherapy

Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles

Intervention Type DRUG

Customized Treatment

Mutated EGFR : Erlotinib 150mg/day (1 year)

Wild-type EGFR or "undetermined" depends on ERCC1 status :

* ERCC1 high : no treatment
* ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted)
* Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)
* Performance status (PS) = 0 or 1
* 18 years \<= age \< 70 years
* Signed inform consent

Exclusion Criteria

* Squamous cell carcinoma
* Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix
* Inadequate renal or cardiac functions
* Pregnant women
* Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Charles SORIA, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Gustave Roussy (IGR)

Marie Wislez, Pr

Role: PRINCIPAL_INVESTIGATOR

APHP - Hôpital Tenon (Paris)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier

Aix-en-Provence, , France

Site Status

Clinique de L'Europe

Amiens, , France

Site Status

Angers - CHU

Angers, , France

Site Status

Centre Hospitalier

Béziers, , France

Site Status

Centre F. Baclesse

Caen, , France

Site Status

CHU - Pneumologie

Caen, , France

Site Status

Centre Hospitalier

Chauny, , France

Site Status

Chevilly Larue - CH

Chevilly-Larue, , France

Site Status

Hôpital Percy-Armées - Pneumologie

Clamart, , France

Site Status

Clermont Ferrand - CHU

Clermont-Ferrand, , France

Site Status

Colmar - CH

Colmar, , France

Site Status

Dax - CH

Dax, , France

Site Status

Ermont - Clinique Claude Bernard

Ermont, , France

Site Status

CHU Grenoble - pneumologie

Grenoble, , France

Site Status

Le Mans - CHG

Le Mans, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Lyon - Hôpital Louis Pradel (Pneumologie)

Lyon, , France

Site Status

Mantes La Jolie - CH

Mantes-la-Jolie, , France

Site Status

APHM - Hôpital Sainte Marguerite

Marseille, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

Metz - Belle Isle

Metz, , France

Site Status

Mont de Marsan - CH

Mont-de-Marsan, , France

Site Status

Montpellier - Clinique Clémentville

Montpellier, , France

Site Status

Mulhouse - CH

Mulhouse, , France

Site Status

Nancy - Polyclinique Gentilly

Nancy, , France

Site Status

Nevers - CH

Nevers, , France

Site Status

Paris - Saint Louis

Paris, , France

Site Status

APHP - Hopital Tenon - Pneumologie

Paris, , France

Site Status

Pau - CH

Pau, , France

Site Status

HCL - Lyon Sud (Pneumologie)

Pierre-Bénite, , France

Site Status

Reims - CHU

Reims, , France

Site Status

Rennes - CHU

Rennes, , France

Site Status

Centre Hospitalier

Saint-Quentin, , France

Site Status

Nouvel Hopital Civil

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Centre Hospitalier Intercommunal

Toulon, , France

Site Status

CHU Toulouse - Pneumologie

Toulouse, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Tours - CHU

Tours, , France

Site Status

Nancy - CHU

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Centre Hospitalier Intercommunal

Villeneuve-Saint-Georges, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Wislez M, Barlesi F, Besse B, Mazieres J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Perol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17.

Reference Type RESULT
PMID: 24638013 (View on PubMed)

Oudart JB, Garinet S, Leger C, Barlesi F, Mazieres J, Jeannin G, Audigier-Valette C, Morot-Sibilot D, Langlais A, Amour E, Mathiot N, Birsen G, Blons H, Wislez M. STK11/LKB1 alterations worsen the poor prognosis of KRAS mutated early-stage non-squamous non-small cell lung carcinoma, results based on the phase 2 IFCT TASTE trial. Lung Cancer. 2024 Apr;190:107508. doi: 10.1016/j.lungcan.2024.107508. Epub 2024 Feb 19.

Reference Type DERIVED
PMID: 38428265 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ifct.fr

IFCT official website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eudract : 2008-004939-38

Identifier Type: -

Identifier Source: secondary_id

IFCT-0801

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adjuvant Pazopanib in Stage I NSCLC
NCT00775307 COMPLETED PHASE2/PHASE3
Chemoradiotherapy of NSCLC Stage IIIB
NCT00198432 COMPLETED PHASE2