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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 18-month Overall Survival Rate | Percentage of patient alive 18 months after registration | 18 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Trédaniel, MD, PhD | IFCT, GH Paris Saint-Joseph | Principal Investigator |
| Françoise Mornex, MD, PhD | IFCT, HCL Lyon-Sud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Europe | Amiens | France | ||||
| Centre Hospitalier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20351327 | Background | 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. | |
| 21277474 |
| Label | URL |
|---|---|
| IFCT official website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemoradiotherapy + Cetuximab | Chemotherapy + cetuximab + radiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) 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 Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ERBITUX | Drug | 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 |
|
| Radiotherapy | Radiation | 66 Gy (2 Gy by fraction, 5 fractions by week) |
|
| 52.3 months (median duration of follow-up) |
| Annemasse |
| France |
| CHU Besancon - Pneumologie | Besançon | 25000 | France |
| Bordeaux - Polyclinique Nord | Bordeaux | 33300 | France |
| Caen - Centre François Baclesse | Caen | 14000 | France |
| Caen - CHU Côte de Nacre | Caen | 14000 | France |
| CH | Chartres | France |
| CH | Cholet | France |
| CHU | Clermont-Ferrand | France |
| CH | Colmar | France |
| Clinique des Cèdres | Cornebarrieu | France |
| Dijon - CAC | Dijon | 21000 | France |
| CHU Grenoble | Grenoble | 38000 | France |
| Institut d'Oncologie Hartmann | Levallois-Perret | France |
| CHU (Hôpital Calmette) - Pneumologie | Lille | 59000 | France |
| CH | Longjumeau | France |
| Clinique des 4 Pavillons | Lormont | France |
| Hôpital Louis Pradel | Lyon | France |
| Hôpital Nord | Marseille | France |
| Centre Hospitalier | Montélimar | France |
| CHU | Nancy | France |
| CH | Nevers | France |
| Centre Hospitalier | Niort | France |
| APHP - Hopital Tenon - Pneumologie | Paris | 75020 | France |
| Hôpital du Val de Grâce | Paris | France |
| Hôpital Saint-Joseph | Paris | France |
| Perpignan - Centre Catalan d'Oncologie | Perpignan | 66000 | France |
| HCL - Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU | Poitiers | France |
| Centre Hospitalier | Rambouillet | France |
| Reims - CHU | Reims | 51092 | France |
| Institut Jean Godinot | Reims | France |
| Centre Frederic Joliot | Rouen | France |
| Centre Etienne Dolet | Saint-Nazaire | France |
| Hôpitaux Universitaires - Nouvel Hôpital Civil | Strasbourg | 63000 | France |
| Suresnes - Hopital Foch | Suresnes | 92151 | France |
| Tours - CHU | Tours | 37000 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| Background |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemoradiotherapy + Cetuximab | Chemoradiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) 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 Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Smoker | Count of Participants | Participants |
| ||||||||||||||||||
| Stage | Per the 7th edition of UICC/AJCC staging system. The T staging is determined by the size of primary tumour in long axis, or direct extent of the tumour into adjacent structures such as mediastinum or chest wall. The N classification descibes the degree of spread to regional lymph nodes. This remained unchanged in the 7th edition as the new data showed no change in node staging related survival. The M staging defines the presence of metastases beyond regional lymph nodes. Stage IIIA: T1 to T3N2M0 and T4N1M0; Stage IIIB: T1 to T4N3M0, Stage IV: T1 to T4 N1toN3 M1 | Count of Participants | Participants |
| |||||||||||||||||
| Histological subtype | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG Performance status | PS0 : fully active, able to carry on all pre-disease performance without restriction PS1 : Restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work | Count of Participants | Participants |
| |||||||||||||||||
| Unresectability cause | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Eligible population | Posted | Count of Participants | Participants | 16 weeks after inclusion |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 18-month Overall Survival Rate | Percentage of patient alive 18 months after registration | Eligible population | Posted | Number | 95% Confidence Interval | percentage of participant | 18 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | 95% Confidence Interval | Months | 52.3 months (median duration of follow-up) |
|
|
Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemoradiotherapy + Cetuximab | Chemotherapy + cetuximab + radiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) 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 Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week) | 51 | 102 | 26 | 102 | 100 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phlebitis superficial | Vascular disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Vascular disorders | Non-systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| General physical health deterioration | General disorders | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Hyperthermia | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Hemoglobin decreased | Investigations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bone marrow failure | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Carotid artery aneurysm | Nervous system disorders | Non-systematic Assessment |
| ||
| Eye pain | Eye disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Faecaloma | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Aphasia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydratation | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| device related infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | General disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Edema limb | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Vertigo | General disorders | Non-systematic Assessment |
| ||
| Weight loss | General disorders | Non-systematic Assessment |
| ||
| Hemoglobin decreased | Investigations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Platelet count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| dysgueusia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastralgia | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Oral mucosal irritation | Gastrointestinal disorders | Non-systematic Assessment |
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| Pyrosis | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Paronychia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Mycosis | Infections and infestations | Non-systematic Assessment |
|
Non randomized study
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communications Officer | IFCT | +33156811045 | contact@ifct.fr |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000068818 | Cetuximab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| IV |
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| Adenocarcinoma without bronchoalveolar component |
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| Non Small Cell |
|
| Neuroendocrine carcinoma |
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| Non Squamous Non Small Cell |
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