A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced

Обзор

This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).

Подробное описание

Due to heterogeneity of patients with stage I-III Non Small Cell Lung Cancer (NSCLC), there is not a unique common therapeutic approach and there is no consensus about the optimal timing, sequencing and combination of surgery, chemotherapy and radiotherapy across the spectrum of early stage and locally advance disease. Consequently, the choice of local treatment modality can vary across countries and centers.

Первичные конечные точки

• NSCLC treatment approaches in Real-World practice [Срок оценки: Restrospective data capture from January 2018 to January 2021.]
• Percentage of patients discusses in multidisciplinary team [Срок оценки: Restrospective data capture from January 2018 to January 2021]
• Healthcare resource utilization aof different therapeutic approaches [Срок оценки: Restrospective data capture from January 2018 to January 2021.]
• Direct medical costs of different therapeutic approaches [Срок оценки: Restrospective data capture from January 2018 to January 2021.]

Вторичные конечные точки (1)

• NSCLC treatments timeline in Real-World practice [Срок оценки: Restrospective data capture from January 2018 to January 2021.]

Критерии участия

Критерии включения

• Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021
• Adult patients (aged ≥ 18 years) at the moment of diagnosis
• Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient.

Критерии исключения

• Patients without availability of medical charts or information required
• Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 25 центров

• IRCCS Casa di sollievo dalla sofferenza — San Giovanni Rotondo
• ASST degli Spedali Civili di Brescia — Brescia
• Gemelli Molise — Campobasso
• Humanitas Istituto Clinico Catanese — Catania
• Policlinico Rodolico — Catania
• AOU Careggi — Florence
• IRCCS Policlinico S. Martino — Genova
• AO Papardo — Messina
• … и ещё 17 центров

Публикации

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. PMID 31912902
• Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available. PMID 28881918
• Rosen JE, Keshava HB, Yao X, Kim AW, Detterbeck FC, Boffa DJ. The Natural History of Operable Non-Small Cell Lung Cancer in the National Cancer Database. Ann Thorac Surg. 2016 May;101(5):1850-5. doi: 10.1016/j.athoracsur.2016.01.077. Epub 2016 Apr 1. PMID 27041452
• Jin G, Wang X, Xu C, Sun J, Yuan Z, Wang J, Zhao L. Disparities in survival following surgery among patients with different histological types of N2-III non-small cell lung cancer: a Surveillance, Epidemiology and End Results (SEER) database analysis. Ann Transl Med. 2020 Oct;8(20):1288. doi: 10.21037/atm-20-4357. PMID 33209868
• Ball D, Mai GT, Vinod S, Babington S, Ruben J, Kron T, Chesson B, Herschtal A, Vanevski M, Rezo A, Elder C, Skala M, Wirth A, Wheeler G, Lim A, Shaw M, Schofield P, Irving L, Solomon B; TROG 09.02 CHISEL investigators. Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Lancet PMID 30770291
• Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label t PMID 30982687
• Senan S, Brade A, Wang LH, Vansteenkiste J, Dakhil S, Biesma B, Martinez Aguillo M, Aerts J, Govindan R, Rubio-Viqueira B, Lewanski C, Gandara D, Choy H, Mok T, Hossain A, Iscoe N, Treat J, Koustenis A, San Antonio B, Chouaki N, Vokes E. PROCLAIM: Randomized Phase III Trial of Pemetrexed-Cisplatin or Etoposide-Cisplatin Plus Thoracic Radiation Therapy Followed by Consolidation Chemotherapy in Loca PMID 26811519
• Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage PMID 25601342

Идентификаторы

NCT: NCT06467383 · NIS009903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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