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This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.
This is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry (TTR) data base and the data from stage IIIA clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
The primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
It is estimated that around 15-20 Spanish sites are enrolling patients with these characteristics in the TTR or in the stage IIIA clinical trials of the Fundación GECP.
Pathologists and physician's of these sites will be invited to participate in the PLANET study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. Each pathologist will re-evaluate the specimens from the selected patients under common criteria.The sample size would be 150 patients enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: platinum-based neoadjuvant treatment and surgery. | Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients. | Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response. | From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the percentage of residual viable tumor in this population of patients under common criteria | A) No response or more than 70% of viable tumor: Lymph node major pathological response negative (LN-MPR)- B) ≤70% of viable tumor cells: Lymph node major pathological response positive (LN-MPR)+ C) No evidence of any viable tumor (including primary tumor): Complete pathological response | From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include all resectable stage IIIA patients who have received platinum-based neoadjuvant treatment and surgery and that were diagnosed as stage IIIA from 2010 to 2017.The cohort of patients identified for the current study will be based on a portion of patients included in the Thoracic Tumor Registry (TTR) and in stage IIIA clinical trials approved by Spanish Health Authorities which the sponsor is Fundación GECP.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Pereira | Contact | +34934302006 | gecp@gecp.org |
| Name | Affiliation | Role |
|---|---|---|
| Mariano Provencio, MD | President of Grupo Español de Cáncer de Pulmón | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario De A Coruna | Recruiting | A Coruña | A Coruña | 15006 | Spain |
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| Label | URL |
|---|---|
| Web page of the sponsor where users can find more information about Fundación GECP studies | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Carboplatin | Drug | Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. |
|
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| To describe the histopathological changes within tumor bed associated to tumor response | Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others | From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months |
| To correlate pathological response and post-surgical complications | Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response. | From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months |
| To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival | Downstaging after surgery is a reduction in the stage of a cancer. Overall Survival defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive. | From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months |
| Hospital General Universitario de Alicante | Recruiting | Alicante | Alicante | 03010 | Spain |
|
| ICO Badalona, Hospital Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| Hospital Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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| ICO Hospitalet | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| Hospital Universitario Insular de Gran canaria | Recruiting | Las Palmas de Gran Canaria | Gran Canaria | 35016 | Spain |
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| Hospital Dr. Negrín | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
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| Hospital Clínico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | Madrid | 28040 | Spain |
|
| Hospital 12 De Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
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| Hospital Universitario la Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
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| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | Madrid | 28222 | Spain |
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| Hospital Universitario Regional de Málaga | Recruiting | Málaga | Málaga | 29010 | Spain |
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| Complejo Hospitalario Universitario de Vigo | Recruiting | Vigo | Pontevedra | 36036 | Spain |
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| Hospital Universitario La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| Hospital Universitario Cruces | Recruiting | Barakaldo | Vizcaya | 48903 | Spain |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |