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

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ClinicalTrials.gov Identifier: NCT01102231
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

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.

Condition or disease Intervention/treatment Phase
Stage III Non-small Cell Lung Cancer Drug: Chemotherapy Drug: ERBITUX Radiation: Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : March 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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)




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 18-month Overall Survival Rate [ Time Frame: 18 months ]
    Percentage of patient alive 18 months after registration

  2. 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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102231


Locations
Show Show 38 study locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
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Principal Investigator: Jean Trédaniel, MD, PhD IFCT, GH Paris Saint-Joseph
Principal Investigator: Françoise Mornex, MD, PhD IFCT, HCL Lyon-Sud
Additional Information:
Publications:
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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01102231    
Other Study ID Numbers: IFCT-0803
First Posted: April 13, 2010    Key Record Dates
Results First Posted: February 16, 2021
Last Update Posted: February 16, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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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
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents