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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000067-15 | EudraCT Number |
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Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Control group | Active Comparator | Control group: *Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four. |
|
| 2 Experimental group | Experimental | Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel/Cisplatin control | Drug | Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Overall Survival | To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bartomeu Massutà Sureda, MD | Hospital General Universitario de Alicante | Study Chair |
| Jose Miguel Sanchez Torres, MD | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Elche | Elche | Alicante | 03202 | Spain | ||
| Ico - H. Germans Trias I Pujol |
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| Label | URL |
|---|---|
| Spanish Lung Cancer Group website | View source |
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Screening details:
Experimental arm: according to the BRAC1 levels of the tumor tissue, receive different combination of treatment.
The recruitment was 500 patients (intention to treat patient) in 47 centers between June 2007 and May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4. |
| FG001 | Experimental Arm | Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Docetaxel | Drug | Docetaxel 75 mg/m2 day 1, 4 cycles |
|
|
| Gemcitabine/Cisplatin | Drug | Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles |
|
|
| Docetaxel/Cisplatin | Drug | Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles |
|
|
| Badalona |
| Barcelona |
| 08916 |
| Spain |
| Hospital D'Althaia | Manresa | Barcelona | 08243 | Spain |
| Hospital de Mataró | Mataró | Barcelona | 08034 | Spain |
| Hospital Provincial de Castellón | Castellon | Castellón | Spain |
| Hospital Insular de Gran Canaria | Las Palmas de Gran Canaria | GRAN Canaria | Spain |
| Hospital Clin. Univ. Santiago de Compostela | Santiago de Compostela | LA Coruna | 15076 | Spain |
| Hospital San Pedro | Logroño | La Rioja | 26004 | Spain |
| F.H.Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Hospital Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | Spain |
| Hospital de La Ribera | Alzira | Valencia | 46600 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | Spain |
| H.G.U. Alicante | Alicante | 03010 | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Univ. Sagrat Cor | Barcelona | 08036 | Spain |
| Instituto Universitario Dexeus | Barcelona | 28036 | Spain |
| Hospital Reina SofÃa | Córdoba | 14004 | Spain |
| Ico-Girona (Hospital Josep Trueta) | Girona | 17007 | Spain |
| Hospital Virgen de Las Nieves | Granada | 18015 | Spain |
| Hospital de Jaén | Jaén | 23007 | Spain |
| Hospital de León | León | Spain |
| Hospital Arnau de Vilanova | Lleida | 46015 | Spain |
| Hospital 12 de Octubre | Madrid | 28006 | Spain |
| Hospital ClÃnico San Carlos | Madrid | 28006 | Spain |
| Hospital de La Princesa | Madrid | 28006 | Spain |
| Md Anderson Internacional | Madrid | 28033 | Spain |
| Fundación Jiménez DÃaz | Madrid | 28040 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Carlos Haya | Málaga | 29010 | Spain |
| Hospital Morales Messeguer | Murcia | 30008 | Spain |
| ClÃnica Rotger | Palma de Mallorca | 07012 | Spain |
| Hospital Son Dureta | Palma de Mallorca | 07014 | Spain |
| Hospital Son Llátzer | Palma de Mallorca | 07198 | Spain |
| Hospital Clinico de Salamanca | Salamanca | 37007 | Spain |
| Hospital de Donostia | San Sebastián | 20014 | Spain |
| Instituto Oncológico de San Sebastián | San Sebastián | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
| H. Arnau de Vilanova | Valencia | 46015 | Spain |
| Hospital General de Valencia | Valencia | Spain |
| Instituto Valenciano de OncologÃa | Valencia | Spain |
| Hospital Provincial de Zamora | Zamora | 49012 | Spain |
| Hospital Lozano Blesa | Zaragoza | Spain |
| Hospital Miguel Servet | Zaragoza | Spain |
| COMPLETED |
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| NOT COMPLETED |
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|
This analisys only include those patients validated by protocol. Patients not valid by protocol will be all those who, having given their informed consent do not receive the study treatment because of any reason and/or those patients who after treatment with chemotherapy do not have a minimum of six months of follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Docetaxel/Cisplatin: Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: 4. |
| BG001 | Experimental Arm | Experimental group, according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned:
|
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Smoking habit | Number | participants |
| ||||||||||||||||
| Histology | Number | participants |
| ||||||||||||||||
| Staging T | T: Tumour's Classification by Size T1= Tumour < 3 cm in greatest dimension, surrounded by lung or visceral pleura, without bronchoscopic evidence of invasion more proximal than the lobar bronchus T2= Tumour > 3 cm but < 7 cm or tumour T3= Tumour > 7 cm or one that directly invades any of the following: Chest wall, diaphragm, phrenic nerve, mediastinal pleura, parietal pericardium Tumour in the main bronchus < 2 cm distal to the carina but without involvement of the carina. Associated atelectasis or obstructive pneumonitis of the entire lung Separate tumour nodule(s) in the same lobe | Number | participants |
| |||||||||||||||
| Staging N | N: Nodes NX:Regional lymph nodes cannot be assessed N0:No regional lymph node metastasis N1:Metastasis in ipsilateral peribronchial and/or ipsilateral hilar lymph nodes and intrapulmonary nodes, including involvement by direct extension N2:Metastasis in ipsilateral mediastinal and/or subcarinal lymph node(s) N3:Metastasis in contralateral mediastinal, contralateral hilar, ipsilateral or contralateral | Number | participants |
| |||||||||||||||
| Stage | Staging is a classification where cancer is located, if or where it has spread and whether it's affecting other parts of the body. There are 5 stages for NSCLC (0,I-IV) Stage IIA: tumor larger than 4 cm but 5 cm or less in size that hasn't spread to the nearby lymph nodes. Stage IIB: tumor that is 5 cm or less in size that has spread to the lymph nodes within the lung, called the N1 lymph nodes. A stage IIB cancer can also be a tumor more than 5 cm wide that has not spread to the lymph nodes. Stage III: cancer spread to the lymph nodes but haven't spread to other distant parts of the body | Number | participants |
| |||||||||||||||
| Treatment according to BRCA1 level | Number | participants |
| ||||||||||||||||
| Treatment compliance | Number | participants |
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| 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 | Estimated Overall Survival | To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion. | Only those patients validated by protocol. Patients not valid by protocol will be all those who, having given their informed consent do not receive the study treatment because of any reason and/or those patients who after treatment with chemotherapy do not have a minimum of six months of follow-up. | Posted | Number | 95% Confidence Interval | proportion of participants | 5 years |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Free Survival | To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease. | Participants are analyzed by protocol. | Posted | Median | 80% Confidence Interval | Month | 5 years |
|
|
70 month
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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 | Control Group | Control group - Docetaxel 75 mg/m2, y cisplatin 75 mg/m2, both day 1 every 21 days. Total cycles: 4. | 3 | 108 | 36 | 108 | 105 | 108 |
| EG001 | Experimental Group:All Reported Adverse Events Related to Study Medication | Include participants in experimental arm Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
| 8 | 392 | 66 | 392 | 384 | 392 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary thromboembolism | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Thrombolysis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Anorexy | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vomits | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acute kidney failure | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Palmoplantar disease | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Broken arm | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phlebitis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Leukocites | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Epistaxis | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Edema | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sensitivity in sensory processing | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Anorexy | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Epigastralgia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| GGT alteration | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Creatinine alteration | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| GPT/ GOT alterations | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| LDH alteration | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Pereira | Fundación GECP | +34 934302006 | epereira@gecp.org |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
|
| Smoker |
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| Never smoker |
|
| Squamous |
|
| Other |
|
| T2 |
|
| T3 |
|
| N2 |
|
| IIB |
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| IIIA |
|
| Experimental: BRCA1 Low: Gemcitabine / Cisplatin |
|
| Experimental BRCA1 medium: Docetaxel / Cisplatin |
|
| Experimental BRCA1 High: Docetaxel |
|
| Not completed |
|
| Control arm vs Gemcitabine /Cisplatin Experimental arm |
|
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| Control arm vs Docetaxel /Cisplatin Experimental arm |
|
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| Control arm vs Docetaxel Experimental Arm |
|
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