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

Phase 2

Completed

• Conditions: Stage III Non-small Cell Lung Cancer
• Interventions: Drug: Chemotherapy; Drug: ERBITUX; Radiation: Radiotherapy

• Registration Number: NCT01102231
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-10
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2014-01
• Study Completion: 2015-12
• Status Verified: 2021-01
• Results First Submitted: 2021-01-06
• Results First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Results First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Chemotherapy	Chemoradiotherapy
A	ERBITUX	Chemoradiotherapy
A	Radiotherapy	Chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Disease-Control Rate	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

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

Trial Locations

Locations (29)

Clinique de l'Europe; 🇫🇷 Amiens, France

Centre Hospitalier; 🇫🇷 Rambouillet, France

CHU Besancon - Pneumologie; 🇫🇷 Besancon, France

Bordeaux - Polyclinique Nord; 🇫🇷 Bordeaux, France

Caen - Centre François Baclesse; 🇫🇷 Caen, France

Caen - CHU Côte de Nacre; 🇫🇷 Caen, France

CH; 🇫🇷 Nevers, France

CHU; 🇫🇷 Poitiers, France

Clinique des Cèdres; 🇫🇷 Cornebarrieu, France

Dijon - CAC; 🇫🇷 Dijon, France

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