Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

January 28, 2021 updated by: Intergroupe Francophone de Cancerologie Thoracique

Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Clinique de l'Europe
      • Annemasse, France
        • Centre Hospitalier
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Bordeaux, France, 33300
        • Bordeaux - Polyclinique Nord
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France, 14000
        • Caen - CHU Côte de Nacre
      • Chartres, France
        • CH
      • Cholet, France
        • CH
      • Clermont-Ferrand, France
        • CHU
      • Colmar, France
        • CH
      • Cornebarrieu, France
        • Clinique des Cèdres
      • Dijon, France, 21000
        • Dijon - CAC
      • Grenoble, France, 38000
        • CHU Grenoble
      • Levallois, France
        • Institut d'Oncologie Hartmann
      • Lille, France, 59000
        • CHU (Hôpital Calmette) - Pneumologie
      • Longjumeau, France
        • CH
      • Lormont, France
        • Clinique des 4 Pavillons
      • Lyon, France
        • Hopital Louis Pradel
      • Marseille, France
        • Hopital Nord
      • Montélimar, France
        • Centre Hospitalier
      • Nancy, France
        • CHU
      • Nevers, France
        • CH
      • Niort, France
        • Centre Hospitalier
      • Paris, France, 75020
        • APHP - Hopital Tenon - Pneumologie
      • Paris, France
        • Hôpital Saint-Joseph
      • Paris, France
        • Hôpital du Val de Grâce
      • Perpignan, France, 66000
        • Perpignan - Centre Catalan d'Oncologie
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud
      • Poitiers, France
        • CHU
      • Rambouillet, France
        • Centre Hospitalier
      • Reims, France, 51092
        • Reims - CHU
      • Reims, France
        • Institut Jean Godinot
      • Rouen, France
        • Centre Frédéric JOLIOT
      • Saint-Nazaire, France
        • Centre Etienne DOLET
      • Strasbourg, France, 63000
        • Hopitaux Universitaires - Nouvel Hopital Civil
      • Suresnes, France, 92151
        • Suresnes - Hopital Foch
      • Tours, France, 37000
        • Tours - CHU
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • non-squamous stage III non-small cell lung cancer
  • measurable disease (RECIST 1.1)
  • ECOG performance status 0-1
  • normal organ and marrow function

Exclusion Criteria:

  • prior chest radiation therapy
  • history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
  • Prior therapy with known specific inhibitors of the EGFR.
  • history of severe allergic reaction to prior therapy with monoclonal antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Chemoradiotherapy
Drug: Chemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
Drug: ERBITUX
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
Radiation: Radiotherapy
66 Gy (2 Gy by fraction, 5 fractions by week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Control Rate
Time Frame: 16 weeks after inclusion

percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
16 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18-month Overall Survival Rate
Time Frame: 18 months
Percentage of patient alive 18 months after registration
18 months
Progression Free Survival
Time Frame: 52.3 months (median duration of follow-up)

Progression-free survival is defined as time between date of inclusion and progression or all-cause death.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
52.3 months (median duration of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Investigators

  • Principal Investigator: Jean Trédaniel, MD, PhD, IFCT, GH Paris Saint-Joseph
  • Principal Investigator: Françoise Mornex, MD, PhD, IFCT, HCL Lyon-Sud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 10, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-0803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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