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

Primary Purpose

Stage III Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Chemotherapy
ERBITUX
Radiotherapy
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique de l'Europe
  • Centre Hospitalier
  • CHU Besancon - Pneumologie
  • Bordeaux - Polyclinique Nord
  • Caen - Centre François Baclesse
  • Caen - CHU Côte de Nacre
  • CH
  • CH
  • CHU
  • CH
  • Clinique des Cèdres
  • Dijon - CAC
  • CHU Grenoble
  • Institut d'Oncologie Hartmann
  • CHU (Hôpital Calmette) - Pneumologie
  • CH
  • Clinique des 4 Pavillons
  • Hôpital Louis Pradel
  • Hôpital Nord
  • Centre Hospitalier
  • CHU
  • CH
  • Centre Hospitalier
  • APHP - Hopital Tenon - Pneumologie
  • Hôpital du Val de Grâce
  • Hôpital Saint-Joseph
  • Perpignan - Centre Catalan d'Oncologie
  • HCL - Lyon Sud
  • CHU
  • Centre Hospitalier
  • Reims - CHU
  • Institut Jean Godinot
  • Centre Frederic Joliot
  • Centre Etienne Dolet
  • Hôpitaux Universitaires - Nouvel Hôpital Civil
  • Suresnes - Hopital Foch
  • Tours - CHU
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Chemoradiotherapy

Outcomes

Primary Outcome Measures

Disease-Control Rate
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).

Secondary Outcome Measures

18-month Overall Survival Rate
Percentage of patient alive 18 months after registration
Progression Free Survival
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.

Full Information

First Posted
April 10, 2010
Last Updated
January 28, 2021
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
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1. Study Identification

Unique Protocol Identification Number
NCT01102231
Brief Title
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Official Title
Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2010 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
Intervention Type
Drug
Intervention Name(s)
ERBITUX
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
66 Gy (2 Gy by fraction, 5 fractions by week)
Primary Outcome Measure Information:
Title
Disease-Control Rate
Description
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).
Time Frame
16 weeks after inclusion
Secondary Outcome Measure Information:
Title
18-month Overall Survival Rate
Description
Percentage of patient alive 18 months after registration
Time Frame
18 months
Title
Progression Free Survival
Description
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.
Time Frame
52.3 months (median duration of follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Trédaniel, MD, PhD
Organizational Affiliation
IFCT, GH Paris Saint-Joseph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Françoise Mornex, MD, PhD
Organizational Affiliation
IFCT, HCL Lyon-Sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de l'Europe
City
Amiens
Country
France
Facility Name
Centre Hospitalier
City
Annemasse
Country
France
Facility Name
CHU Besancon - Pneumologie
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Bordeaux - Polyclinique Nord
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Caen - Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Caen - CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CH
City
Chartres
Country
France
Facility Name
CH
City
Cholet
Country
France
Facility Name
CHU
City
Clermont-Ferrand
Country
France
Facility Name
CH
City
Colmar
Country
France
Facility Name
Clinique des Cèdres
City
Cornebarrieu
Country
France
Facility Name
Dijon - CAC
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Institut d'Oncologie Hartmann
City
Levallois
Country
France
Facility Name
CHU (Hôpital Calmette) - Pneumologie
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CH
City
Longjumeau
Country
France
Facility Name
Clinique des 4 Pavillons
City
Lormont
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
Country
France
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Name
Centre Hospitalier
City
Montélimar
Country
France
Facility Name
CHU
City
Nancy
Country
France
Facility Name
CH
City
Nevers
Country
France
Facility Name
Centre Hospitalier
City
Niort
Country
France
Facility Name
APHP - Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital du Val de Grâce
City
Paris
Country
France
Facility Name
Hôpital Saint-Joseph
City
Paris
Country
France
Facility Name
Perpignan - Centre Catalan d'Oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
HCL - Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU
City
Poitiers
Country
France
Facility Name
Centre Hospitalier
City
Rambouillet
Country
France
Facility Name
Reims - CHU
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Centre Frederic Joliot
City
Rouen
Country
France
Facility Name
Centre Etienne Dolet
City
Saint-Nazaire
Country
France
Facility Name
Hôpitaux Universitaires - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
63000
Country
France
Facility Name
Suresnes - Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Tours - CHU
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20351327
Citation
Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
Results Reference
background
PubMed Identifier
21277474
Citation
Tredaniel J, Mornex F, Barillot I, Diaz O, Hennequin C, Le Pechoux C, Lavole A, Giraud P, Souquet PJ, Teixeira L, Vaylet F, Zalcman G, Baudrin L, Morin F, Milleron B. [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]. Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11. French.
Results Reference
background
Links:
URL
http://www.ifct.fr
Description
IFCT official website

Learn more about this trial

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

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